Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma

SparkCures ID	1098
Trial Phase	Phase 3
Enrollment	1450 Patients
Treatments	Bortezomib Daratumumab Dexamethasone Lenalidomide
Tags	CD38 Monoclonal Antibody
Trial Sponsors	Eastern Cooperative Oncology Group (ECOG)
Trial Collaborators	National Cancer Institute (NCI)
NCT Identifier	NCT04566328

Inclusion Criteria:

STEP 0 - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)
STEP 0 - Patient must have newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria
STEP 0 - Patient must agree to register to the mandatory REVLIMID Risk Evaluation and Mitigation Strategy (RevREMS) program and be willing and able to comply with the requirements of RevREMS
STEP 0 - Patient must be able to undergo diagnostic bone marrow aspirate following preregistration.
- NOTE: Bone marrow aspirate specimen must be submitted to Adaptive Biotechnologies for clonoSEQ Assay
- NOTE: Adaptive Biotechnologies will release results to the diagnostic Portal from the Clonality (ID) test within fourteen (14) days of receipt and reconciliation of fresh bone marrow specimen to the submitting institution
STEP 1 - Patient must meet all eligibility criteria in STEP 0 with exception of allergy requirement
STEP 1 - Institution must have received the Clonality (ID) test results from Adaptive Biotechnologies and dominant sequences were identified
STEP 1 - Patient must have standard risk MM as defined by the Revised International Staging System (RISS) stage I or II
- NOTE: R-ISS stage is based on serum beta2 microglobulin, albumin and lactate dehydrogenase (LDH) levels along with presence of chromosomal abnormalities (CA) detected by interphase fluorescent in situ hybridization (iFISH). Presence of del(17p), t(4;14), and/or t(14;16) is considered high risk and absence of these, including any other findings, are standard risk
- R-ISS stage
  - Stage I: ISS stage I [beta2 macroglobulin < 3.5 mg/L, albumin > 3.5 g/dL] AND standard-risk CA AND normal LDH
  - Stage II: Not R-ISS stage I or III
  - Stage III: ISS stage III [beta2 macroglobulin > 5.5 mg/L] AND high-risk CA OR high LDH (> upper limit of normal) [patients with stage III are ineligible]
STEP 1 - Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to registration:
- >= 1 g/dL monoclonal protein (M-protein) on serum protein electrophoresis
- >= 200 mg/24 hours of monoclonal protein on a 24-hour urine protein electrophoresis
- Involved free light chain >= 10 mg/dL or >= 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (< 0.26 or > 1.65)
- Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)
STEP 1 - Patients must have a serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay performed within 28 days prior to registration. In addition, a bone marrow biopsy and/or aspirate is required within 28 days if bone marrow is being followed for response
- NOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hr. Please note that if both serum and urine M-components are present, both must be followed in order to evaluate response
- NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine. Measurable disease in the serum is defined as having a serum M-spike >= 1 g/dL. Measurable disease in the urine is defined as having a urine M-spike >= 200 mg/24 hr
STEP 1 - Calculated creatinine clearance > 30 mL/min (obtained =< 14 days prior to Step 1 registration)
STEP 1 - Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 14 days prior to Step 1 registration)
STEP 1 - Untransfused platelet count >= 75,000/mm^3 (obtained =< 14 days prior to Step 1 registration)
STEP 1 - Hemoglobin >= 8.0 g/dL (obtained =< 14 days prior to Step 1 registration)
STEP 1 - Total bilirubin =< 1.5 x ULN (institutional upper limit of normal) (obtained =< 14 days prior to Step 1 registration)
STEP 1 - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (obtained =< 14 days prior to Step 1 registration)
STEP 1 - Patient must have received no more than one cycle (28 days or less) of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. Patient must not have been exposed to daratumumab for treatment of symptomatic myeloma. Prior radiation therapy to symptomatic lesions is allowed provided there are no residual toxicity related to radiation and blood counts meet the study requirements. Radiation treatment must be completed at least 14 days prior to Step 1 registration
STEP 1 - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
STEP 1 - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
STEP 1 - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
STEP 1 - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
STEP 1 - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients must not have evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within 6 months prior to Step 1 registration
STEP 1 - Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation
STEP 1 - Patients with a history of chronic obstructive pulmonary disease (COPD) must have FEV1 testing done within 28 days prior to Step 1 registration and the forced expiratory volume in 1 second (FEV1) must be > 50% of predicted normal
STEP 2 - Institution must have received Tracking (MRD) test results from Adaptive Biotechnologies
STEP 2 - Patient must have completed the Step 1 Induction phase of this protocol without experiencing progression
STEP 2 - Patient must be registered to Step 2 within 8 weeks of completing Step 1 Induction Treatment, counting from last day of completion of last cycle
STEP 2 - Patient must have an ECOG performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)
STEP 2 - Any adverse event(s) related to Step 1 Induction Treatment must have resolved to grade 2 or less
STEP 2 - Hemoglobin >= 8 g/dL (obtained within 14 days prior to Step 2 randomization)
STEP 2 - Platelet count >= 50,000/mm^3 (obtained within 14 days prior to Step 2 randomization)
STEP 2 - Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained within 14 days prior to Step 2 randomization)
STEP 2 - Calculated creatinine clearance >= 30 mL/min (obtained within 14 days prior to Step 2 randomization)
STEP 2 - Total bilirubin =< 1.5 x ULN (Institutional upper limit of normal) (obtained within 14 days prior to Step 2 randomization)
STEP 2 - ALT and AST < 3 x ULN (obtained within 14 days prior to Step 2 randomization)

Exclusion Criteria:

STEP 0 - Patient must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure), or known sensitivity to mammalian-derived products
STEP 1 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 1 registration to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
- Has achieved menarche at some point,
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
STEP 1 - Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception (for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months days after the last dose of protocol treatment) OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). Men must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment
STEP 1 - Patient must not have peripheral neuropathy >= grade 2 on clinical examination or grade 1 with pain at time of Step 1 registration
STEP 1 - Patient must not have any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
STEP 1 - Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification
- NOTE: Patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to register
STEP 1 - Patient must not receive any other concurrent chemotherapy, or any ancillary therapy considered investigational while on this protocol
- NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
STEP 2 - Patient must not have received any non-protocol therapy outside of the assigned Step 1 Induction treatment including stem cell transplant
STEP 2 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 2 randomization to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
- Has achieved menarche at some point,
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
STEP 2 - Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception (for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months days after the last dose of protocol treatment) OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).

Men must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment

The following criteria is provided for health care professionals.

Inclusion Criteria:

STEP 0 - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)
STEP 0 - Patient must have newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria
STEP 0 - Patient must agree to register to the mandatory REVLIMID Risk Evaluation and Mitigation Strategy (RevREMS) program and be willing and able to comply with the requirements of RevREMS
STEP 0 - Patient must be able to undergo diagnostic bone marrow aspirate following preregistration.
- NOTE: Bone marrow aspirate specimen must be submitted to Adaptive Biotechnologies for clonoSEQ Assay
- NOTE: Adaptive Biotechnologies will release results to the diagnostic Portal from the Clonality (ID) test within fourteen (14) days of receipt and reconciliation of fresh bone marrow specimen to the submitting institution
STEP 1 - Patient must meet all eligibility criteria in STEP 0 with exception of allergy requirement
STEP 1 - Institution must have received the Clonality (ID) test results from Adaptive Biotechnologies and dominant sequences were identified
STEP 1 - Patient must have standard risk MM as defined by the Revised International Staging System (RISS) stage I or II
- NOTE: R-ISS stage is based on serum beta2 microglobulin, albumin and lactate dehydrogenase (LDH) levels along with presence of chromosomal abnormalities (CA) detected by interphase fluorescent in situ hybridization (iFISH). Presence of del(17p), t(4;14), and/or t(14;16) is considered high risk and absence of these, including any other findings, are standard risk
- R-ISS stage
  - Stage I: ISS stage I [beta2 macroglobulin < 3.5 mg/L, albumin > 3.5 g/dL] AND standard-risk CA AND normal LDH
  - Stage II: Not R-ISS stage I or III
  - Stage III: ISS stage III [beta2 macroglobulin > 5.5 mg/L] AND high-risk CA OR high LDH (> upper limit of normal) [patients with stage III are ineligible]
STEP 1 - Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to registration:
- >= 1 g/dL monoclonal protein (M-protein) on serum protein electrophoresis
- >= 200 mg/24 hours of monoclonal protein on a 24-hour urine protein electrophoresis
- Involved free light chain >= 10 mg/dL or >= 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (< 0.26 or > 1.65)
- Monoclonal bone marrow plasmacytosis >= 30% (evaluable disease)
STEP 1 - Patients must have a serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay performed within 28 days prior to registration. In addition, a bone marrow biopsy and/or aspirate is required within 28 days if bone marrow is being followed for response
- NOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is >= 200 mg/24 hr. Please note that if both serum and urine M-components are present, both must be followed in order to evaluate response
- NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine. Measurable disease in the serum is defined as having a serum M-spike >= 1 g/dL. Measurable disease in the urine is defined as having a urine M-spike >= 200 mg/24 hr
STEP 1 - Calculated creatinine clearance > 30 mL/min (obtained =< 14 days prior to Step 1 registration)
STEP 1 - Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 14 days prior to Step 1 registration)
STEP 1 - Untransfused platelet count >= 75,000/mm^3 (obtained =< 14 days prior to Step 1 registration)
STEP 1 - Hemoglobin >= 8.0 g/dL (obtained =< 14 days prior to Step 1 registration)
STEP 1 - Total bilirubin =< 1.5 x ULN (institutional upper limit of normal) (obtained =< 14 days prior to Step 1 registration)
STEP 1 - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (obtained =< 14 days prior to Step 1 registration)
STEP 1 - Patient must have received no more than one cycle (28 days or less) of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. Patient must not have been exposed to daratumumab for treatment of symptomatic myeloma. Prior radiation therapy to symptomatic lesions is allowed provided there are no residual toxicity related to radiation and blood counts meet the study requirements. Radiation treatment must be completed at least 14 days prior to Step 1 registration
STEP 1 - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
STEP 1 - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
STEP 1 - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
STEP 1 - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
STEP 1 - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients must not have evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within 6 months prior to Step 1 registration
STEP 1 - Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation
STEP 1 - Patients with a history of chronic obstructive pulmonary disease (COPD) must have FEV1 testing done within 28 days prior to Step 1 registration and the forced expiratory volume in 1 second (FEV1) must be > 50% of predicted normal
STEP 2 - Institution must have received Tracking (MRD) test results from Adaptive Biotechnologies
STEP 2 - Patient must have completed the Step 1 Induction phase of this protocol without experiencing progression
STEP 2 - Patient must be registered to Step 2 within 8 weeks of completing Step 1 Induction Treatment, counting from last day of completion of last cycle
STEP 2 - Patient must have an ECOG performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)
STEP 2 - Any adverse event(s) related to Step 1 Induction Treatment must have resolved to grade 2 or less
STEP 2 - Hemoglobin >= 8 g/dL (obtained within 14 days prior to Step 2 randomization)
STEP 2 - Platelet count >= 50,000/mm^3 (obtained within 14 days prior to Step 2 randomization)
STEP 2 - Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained within 14 days prior to Step 2 randomization)
STEP 2 - Calculated creatinine clearance >= 30 mL/min (obtained within 14 days prior to Step 2 randomization)
STEP 2 - Total bilirubin =< 1.5 x ULN (Institutional upper limit of normal) (obtained within 14 days prior to Step 2 randomization)
STEP 2 - ALT and AST < 3 x ULN (obtained within 14 days prior to Step 2 randomization)

Exclusion Criteria:

STEP 0 - Patient must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure), or known sensitivity to mammalian-derived products
STEP 1 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 1 registration to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
- Has achieved menarche at some point,
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
STEP 1 - Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception (for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months days after the last dose of protocol treatment) OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). Men must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment
STEP 1 - Patient must not have peripheral neuropathy >= grade 2 on clinical examination or grade 1 with pain at time of Step 1 registration
STEP 1 - Patient must not have any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
STEP 1 - Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification
- NOTE: Patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to register
STEP 1 - Patient must not receive any other concurrent chemotherapy, or any ancillary therapy considered investigational while on this protocol
- NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
STEP 2 - Patient must not have received any non-protocol therapy outside of the assigned Step 1 Induction treatment including stem cell transplant
STEP 2 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 2 randomization to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
- Has achieved menarche at some point,
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
STEP 2 - Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception (for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months days after the last dose of protocol treatment) OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).

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Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified

UW Carbone Cancer Center University of Wisconsin Health

The following is a listing of trial locations that are not currently open and accepting patients.

Recruiting

Katmai Oncology Group

Anchorage, AK

Recruiting

Providence Alaska Medical Center

Anchorage, AK

Recruiting

Arizona

University of Arizona Cancer Center - North Campus

Tucson, AZ

Recruiting

Banner - University Medical Center Tucson Banner Health

Tucson, AZ

Recruiting

California

Roy and Patricia Disney Family Cancer Center Providence Saint Joseph Medical Center

Burbank, CA

Recruiting

Mission Hope Cancer Center (Santa Maria) Central Coast Medical Oncology

Santa Maria, CA

Recruiting

Colorado

Littleton Adventist Hospital

Centennial, CO

Recruiting

Centura Penrose Hospital

Colorado Springs, CO

Recruiting

Rocky Mountain Cancer Center - Penrose Hospital Colorado Springs

Colorado Springs, CO

Recruiting

St. Francis Medical Center Catholic Health Initiatives

Colorado Springs, CO

Recruiting

Porter Adventist Hospital

Denver, CO

Recruiting

Centura Mercy Hospital

Durango, CO

Recruiting

Centura Southwest Oncology

Durango, CO

Recruiting

Centura St. Anthony Hospital

Lakewood, CO

Recruiting

Centura Longmont United Hospital

Longmont, CO

Recruiting

Rocky Mountain Cancer Centers (Longmont) Longmont

Longmont, CO

Recruiting

Centura Parker Adventist Hospital

Parker, CO

Recruiting

Saint Mary Corwin Medical Center

Pueblo, CO

Recruiting

Connecticut

Smilow Cancer Hospital Care Center (Derby)

Derby, CT

Recruiting

Yale Cancer Center - Smilow Cancer Hospital Care Center Fairfield

Fairfield, CT

Recruiting

Smilow Cancer Hospital Care Center (Glastonbury)

Glastonbury, CT

Recruiting

Smilow Cancer Hospital Care Center

Greenwich, CT

Recruiting

Smilow Cancer Hospital - Shoreline Medical Center Yale New Haven Health

Guilford, CT

Recruiting

Smilow Cancer Hospital at Saint Francis Hospital Trinity Health of New England

Hartford, CT

Recruiting

Yale Cancer Center Smilow Cancer Hospital at Yale-New Haven

New Haven, CT

Recruiting

Yale-New Haven Hospital - North Haven Medical Center

North Haven, CT

Recruiting

Smilow Cancer Hospital Care Center (Orange)

Orange, CT

Recruiting

Smilow Cancer Hospital Care Center (Torrington)

Torrington, CT

Recruiting

Smilow Cancer Hospital Care Center (Trumbull)

Trumbull, CT

Recruiting

Smilow Cancer Hospital - The Harold Leever Regional Cancer Center (Waterbury)

Waterbury, CT

Recruiting

Smilow Cancer Hospital Care Center (Waterford)

Waterford, CT

Recruiting

Delaware

Beebe Medical Center

Lewes, DE

Recruiting

ChristianaCare Hematology

Newark, DE

Recruiting

ChristianaCare Helen F. Graham Cancer Center Christiana Hospital

Newark, DE

Recruiting

Medical Oncology Hematology Consultants PA in ChristianaCare Helen F. Graham Cancer Center & Research Institute

Newark, DE

Recruiting

Christiana Care Health System (Christiana Hospital)

Newark, DE

Recruiting

Beebe Health Campus

Rehoboth Beach, DE

Recruiting

Nanticoke Memorial Hospital

Seaford, DE

Suspended

Christiana Care Health System (Wilmington Hospital)

Wilmington, DE

Recruiting

Florida

Holy Cross Hospital Holy Cross Health, A Member of Trinity Health

Fort Lauderdale, FL

Recruiting

Sacred Heart Medical Oncology Group

Pensacola, FL

Recruiting

Georgia

Grady Memorial Hospital

Atlanta, GA

Recruiting

Idaho

Saint Alphonsus Cancer Care Center (Boise)

Boise City, ID

Recruiting

Kootenai Clinic Cancer Services - Coeur d'Alene

Coeur d'Alene, ID

Recruiting

Saint Luke's Mountain States Tumor Institute (Fruitland)

Fruitland, ID

Recruiting

St. Luke's Cancer Institute (Meridian)

Meridian, ID

Recruiting

Saint Luke's Mountain States Tumor Institute (Nampa)

Nampa, ID

Recruiting

Kootenai Cancer Center

Post Falls, ID

Recruiting

Kootenai Clinic

Sandpoint, ID

Recruiting

Saint Luke's Mountain States Tumor Institute (Twin Falls)

Twin Falls, ID

Recruiting

Illinois

Rush - Copley Medical Center

Aurora, IL

Recruiting

Illinois CancerCare (Bloomington)

Bloomington, IL

Recruiting

Loyola Center for Health at Burr Ridge

Burr Ridge, IL

Recruiting

Illinois CancerCare (Canton)

Canton, IL

Recruiting

Memorial Hospital of Carbondale

Carbondale, IL

Recruiting

SIH Cancer Institute

Carterville, IL

Recruiting

Illinois CancerCare (Carthage)

Carthage, IL

Recruiting

Centralia Oncology Clinic

Centralia, IL

Recruiting

University of Illinois at Chicago

Chicago, IL

Recruiting

Carle Foundation Hospital (Vermilion)

Danville, IL

Recruiting

Cancer Care Specialists of IL - Cancer Care Center of Decatur

Decatur, IL

Recruiting

Memorial Health - Decatur Memorial Hospital Memorial Health

Decatur, IL

Recruiting

Illinois CancerCare-Dixon

Dixon, IL

Recruiting

Carle (Effingham)

Effingham, IL

Recruiting

Cancer Care Specialists (Crossroads Cancer Center)

Effingham, IL

Recruiting

Illinois CancerCare (Eureka)

Eureka, IL

Recruiting

Illinois CancerCare (Galesburg)

Galesburg, IL

Recruiting

Western Illinois Cancer Treatment Center

Galesburg, IL

Recruiting

Northwestern Medicine Cancer Center Delnor

Geneva, IL

Recruiting

Illinois CancerCare (Kewanee)

Kewanee, IL

Recruiting

Illinois CancerCare (Macomb)

Macomb, IL

Recruiting

Carle Foundation Hospital (Mattoon)

Mattoon, IL

Recruiting

Loyola University Medical Center Cardinal Bernardin Cancer Center

Maywood, IL

Recruiting

Marjorie Weinberg Cancer Center at Loyola-Gottlieb

Melrose Park, IL

Recruiting

Good Samaritan Regional Health Center

Mount Vernon, IL

Recruiting

Loyola Center for Cancer Care and Research

Orland Park, IL

Recruiting

Illinois CancerCare - Fox River Cancer Center

Ottawa, IL

Recruiting

Illinois CancerCare - Pekin

Pekin, IL

Recruiting

Illinois CancerCare - Peoria

Peoria, IL

Recruiting

Methodist Medical Center of Illinois

Peoria, IL

Recruiting

Illinois CancerCare - Peru In Valley Regional Cancer Center

Peru, IL

Recruiting

US Oncology - Valley Regional Cancer Center

Peru, IL

Recruiting

Illinois CancerCare - Princeton

Princeton, IL

Recruiting

Southern Illinois University School of Medicine - Simmons Cancer Institute

Springfield, IL

Recruiting

Springfield Clinic

Springfield, IL

Recruiting

Memorial Medical Center

Springfield, IL

Recruiting

Carle Cancer Institute

Urbana, IL

Recruiting

Northwestern Medicine Cancer Center Warrenville

Warrenville, IL

Recruiting

Rush - Copley Healthcare Center

Yorkville, IL

Recruiting

Indiana

IU Simon Cancer Center Indiana University

Indianapolis, IN

Not Yet Recruiting

Reid Health

Richmond, IN

Recruiting

Iowa

Mary Greeley Medical Center

Ames, IA

Recruiting

McFarland Clinic PC

Ames, IA

Recruiting

McFarland Clinic PC (Boone)

Boone, IA

Recruiting

Oncology Associates at Hall-Perrine Cancer Center Mercy Cedar Rapids

Cedar Rapids, IA

Recruiting

Mission Cancer & Blood (Clive) In Clive Cancer Center

Clive, IA

Recruiting

MercyOne Clive Cancer Center

Clive, IA

Recruiting

Alegent Health Mercy Hospital

Council Bluffs, IA

Recruiting

Greater Regional Medical Center

Creston, IA

Recruiting

Medical Oncology and Hematology Associates (Des Moines) in UnityPoint Health - John Stoddard Cancer Center

Des Moines, IA

Recruiting

Broadlawns Medical Center

Des Moines, IA

Recruiting

Mission Cancer MercyOne Cancer Center (Laurel)

Des Moines, IA

Recruiting

MercyOne Des Moines Medical Center

Des Moines, IA

Recruiting

McFarland Clinic Trinity Cancer Center

Fort Dodge, IA

Recruiting

McFarland Clinic PC (Jefferson)

Jefferson, IA

Recruiting

McFarland Clinic PC (Marshalltown)

Marshalltown, IA

Recruiting

UnityPoint Health - Methodist West Hospital

West Des Moines, IA

Recruiting

MercyOne West Des Moines Medical Center

West Des Moines, IA

Recruiting

Kentucky

Flaget Memorial Hospital

Bardstown, KY

Recruiting

Commonwealth Cancer Center (Corbin)

Corbin, KY

Recruiting

Saint Joseph Hospital

Lexington, KY

Recruiting

Saint Joseph Hospital East

Lexington, KY

Recruiting

U of L Health - Jewish Hospital

Louisville, KY

Recruiting

Saints Mary and Elizabeth Hospital

Louisville, KY

Recruiting

Jewish Hospital Medical Center Northeast

Louisville, KY

Recruiting

Jewish Hospital Medical Center South

Shepherdsville, KY

Recruiting

Louisiana

Ochsner LSU Health Shreveport Ochsner Louisiana State University

Shreveport, LA

Recruiting

Maryland

Frederick Health Hospital

Frederick, MD

Recruiting

Massachusetts

Tufts Medical Center Cancer Center

Boston, MA

Recruiting

Michigan

ProMedica Hickman Cancer Center Grace Christman Medical Building

Adrian, MI

Recruiting

Bronson Battle Creek Cancer Care Center

Battle Creek, MI

Recruiting

St. Joseph Mercy Brighton Health Center

Brighton, MI

Recruiting

St. Joseph Mercy Canton Health Center

Canton, MI

Recruiting

St. Joseph Mercy Chelsea Hospital

Chelsea, MI

Recruiting

Genesys Hurley Cancer Institute

Flint, MI

Recruiting

Hurley Medical Center

Flint, MI

Recruiting

Mercy Health Saint Mary's

Grand Rapids, MI

Recruiting

Spectrum Health

Grand Rapids, MI

Recruiting

Bronson Methodist Hospital

Kalamazoo, MI

Recruiting

West Michigan Cancer Center

Kalamazoo, MI

Recruiting

Borgess Medical Center

Kalamazoo, MI

Recruiting

Sparrow Hospital

Lansing, MI

Recruiting

St. Mary Mercy Hospital St. Joe's Health

Livonia, MI

Recruiting

Mercy Health Mercy Campus

Muskegon, MI

Recruiting

Lakeland Community Hospital

Niles, MI

Recruiting

St. Joseph Mercy (Oakland)

Pontiac, MI

Recruiting

Spectrum Health Reed City Hospital

Reed City, MI

Recruiting

Saint Mary's of Michigan

Saginaw, MI

Recruiting

Spectrum Health Lakeland Medical Center

St. Joseph, MI

Recruiting

Spectrum Health Marie Yeager Cancer Center

St. Joseph, MI

Recruiting

Munson Medical Center

Traverse City, MI

Recruiting

Ascension Macomb-Oakland Hospital - Webber Cancer Center

Warren, MI

Recruiting

St. Joseph Mercy Ann Arbor Hospital

Ypsilanti, MI

Recruiting

Minnesota

Sanford Clinic North-Bemidgi

Bemidji, MN

Recruiting

M Health Fairview Ridges Hospital

Burnsville, MN

Recruiting

Cambridge Medical Center

Cambridge, MN

Recruiting

Mercy Hospital

Coon Rapids, MN

Recruiting

Fairview Southdale Hospital

Edina, MN

Recruiting

Unity Hospital

Fridley, MN

Recruiting

Fairview Maple Grove Medical Center

Maple Grove, MN

Recruiting

Minnesota Oncology Maplewood Cancer Center

Maplewood, MN

Recruiting

M Health Fairview St. John's Hospital

Maplewood, MN

Recruiting

Abbott-Northwestern Hospital Allina Health

Minneapolis, MN

Recruiting

Hennepin County Medical Center

Minneapolis, MN

Recruiting

Health Partners Inc.

Minneapolis, MN

Recruiting

Monticello Cancer Center

Monticello, MN

Recruiting

New Ulm Medical Center

New Ulm, MN

Recruiting

Fairview Northland Medical Center

Princeton, MN

Recruiting

North Memorial Medical Health Center

Robbinsdale, MN

Recruiting

Mayo Clinic (Rochester)

Rochester, MN

Recruiting

Saint Francis Regional Medical Center

Shakopee, MN

Recruiting

Park Nicollet Specialty Center at Methodist Hospital

St. Louis Park, MN

Recruiting

Regions Hospital

St. Paul, MN

Recruiting

United Hospital

St. Paul, MN

Recruiting

Lakeview Hospital

Stillwater, MN

Recruiting

Ridgeview Medical Center

Waconia, MN

Recruiting

Rice Memorial Hospital

Willmar, MN

Recruiting

Minnesota Oncology and Hematology PA (Woodbury)

Woodbury, MN

Recruiting

Fairview Lakes Medical Center

Wyoming, MN

Recruiting

Missouri

Saint Louis Cancer and Breast Institute

Ballwin, MO

Recruiting

Central Care Cancer Center

Bolivar, MO

Recruiting

CoxHealth Cancer Center

Branson, MO

Recruiting

Saint Francis Medical Center (Cape Girardeau)

Cape Girardeau, MO

Recruiting

Southeast Cancer Center Southeast Health

Cape Girardeau, MO

Recruiting

Capital Region Medical Center (Goldschmidt Cancer Center)

Jefferson City, MO

Recruiting

Freeman Cornell-Beshore Cancer Institute

Joplin, MO

Recruiting

Mercy Clinic Cancer and Hematology (Rolla)

Rolla, MO

Recruiting

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, MO

Recruiting

Mercy Hospital Springfield

Springfield, MO

Recruiting

CoxHealth South Hospital Cox Medical Center South

Springfield, MO

Recruiting

Heartland Regional Medical Center

St. Joseph, MO

Recruiting

Saint Louis Cancer and Breast Institute (South City)

St. Louis, MO

Recruiting

Mercy Hospital South

St. Louis, MO

Recruiting

Missouri Baptist Medical Cancer Center

St. Louis, MO

Recruiting

Missouri Baptist Sullivan Hospital

Sullivan, MO

Recruiting

Missouri Baptist Outpatient Center (Sunset Hills)

Sunset Hills, MO

Recruiting

Mercy Hospital Washington

Washington, MO

Recruiting

Montana

Community Hospital of Anaconda

Anaconda, MT

Recruiting

Billings Clinic Cancer Center

Billings, MT

Recruiting

Bozeman Deaconess Hospital

Bozeman, MT

Recruiting

Benefis Sletten Cancer Institute

Great Falls, MT

Recruiting

Great Falls Clinic Specialty Center

Great Falls, MT

Recruiting

Kalispell Regional Medical Center

Kalispell, MT

Recruiting

Providence St. Patrick Hospital

Missoula, MT

Recruiting

Community Medical Hospital

Missoula, MT

Recruiting

Nebraska

CHI Health St. Francis

Grand Island, NE

Recruiting

CHI Health Good Samaritan Hospital

Kearney, NE

Recruiting

CHI Health St. Elizabeth St. Elizabeth Regional Medical Center

Lincoln, NE

Recruiting

CHI Health Immanuel Medical Center

Omaha, NE

Recruiting

CHI Health Creighton University Medical Center (Bergan Mercy)

Omaha, NE

Recruiting

CHI Health Lakeside Hospital

Omaha, NE

Recruiting

CHI Health Creighton University Medical Center

Omaha, NE

Recruiting

CHI Health Midlands

Papillion, NE

Recruiting

New Mexico

University of New Mexico Comprehensive Cancer Center

Albuquerque, NM

Recruiting

New York

Glens Falls Hospital

Glens Falls, NY

Recruiting

Stony Brook University Hospital

Stony Brook, NY

Recruiting

North Carolina

Southeastern Medical Oncology Center (Clinton)

Clinton, NC

Recruiting

Southeastern Medical Oncology Center (Goldsboro)

Goldsboro, NC

Recruiting

Southeastern Medical Oncology Center (Jacksonville)

Jacksonville, NC

Recruiting

North Dakota

Sanford Bismarck Medical Center

Bismarck, ND

Recruiting

Sanford Medical Center

Fargo, ND

Recruiting

Sanford Roger Maris Cancer Center

Fargo, ND

Recruiting

Sanford North Fargo Clinic

Fargo, ND

Recruiting

Ohio

Strecker Cancer Center (Belpre)

Belpre, OH

Recruiting

Miami Valley Hospital South

Centerville, OH

Recruiting

Adena Regional Medical Center

Chillicothe, OH

Recruiting

Barrett Cancer Center University of Cincinnati Health

Cincinnati, OH

Recruiting

TriHealth Cancer Institute (Good Samaritan Hospital)

Cincinnati, OH

Recruiting

Oncology Hematology Care Inc. (Kenwood)

Cincinnati, OH

Recruiting

TriHealth Bethesda North Hospital

Cincinnati, OH

Recruiting

University of Cincinnati College of Medicine

Cincinnati, OH

Recruiting

Case Western Reserve University

Cleveland, OH

Recruiting

Columbus Oncology and Hematology Associates

Columbus, OH

Recruiting

OhioHealth Riverside Methodist Hospital

Columbus, OH

Recruiting

OhioHealth Grant Medical Center

Columbus, OH

Recruiting

The Mark H. Zangmeister Center

Columbus, OH

Recruiting

Mount Carmel Health Center West

Columbus, OH

Recruiting

Doctors Hospital

Columbus, OH

Recruiting

Dayton Physicians, LLC

Dayton, OH

Recruiting

Miami Valley Hospital

Dayton, OH

Recruiting

OhioHealth Grady Memorial Hospital Cancer Center

Delaware, OH

Recruiting

Blanchard Valley Hospital

Findlay, OH

Recruiting

TriHealth Cancer Institute (Anderson)

Forestville, OH

Recruiting

Dayton Physicians (Atrium Medical Center)

Franklin, OH

Recruiting

Wayne Healthcare

Greenville, OH

Recruiting

Kettering Medical Center

Kettering, OH

Recruiting

Fairfield Medical Center

Lancaster, OH

Recruiting

Saint Rita's Medical Center

Lima, OH

Recruiting

Marietta Memorial Hospital

Marietta, OH

Recruiting

OhioHealth Marion General Hospital

Marion, OH

Recruiting

UH Seidman Cancer Center (Landerbrook)

Mayfield Heights, OH

Suspended

Premier Health Atrium Medical Center - Middletown

Middletown, OH

Recruiting

Knox Community Hospital

Mount Vernon, OH

Recruiting

Licking Memorial Hospital

Newark, OH

Recruiting

Newark Radiation Oncology

Newark, OH

Recruiting

Southern Ohio Medical Center

Portsmouth, OH

Recruiting

Dayton Physicians (Wilson Memorial Hospital)

Sidney, OH

Recruiting

Springfield Regional Medical Center

Springfield, OH

Recruiting

Saint Vincent Mercy Medical Center

Toledo, OH

Recruiting

Mercy Health - St. Anne Hospital

Toledo, OH

Recruiting

Toledo Clinic Cancer Centers - Toledo

Toledo, OH

Recruiting

Dayton Physicians - Upper Valley Medical Center

Troy, OH

Recruiting

Premier Health Upper Valley Medical Center

Troy, OH

Recruiting

Saint Ann's Hospital

Westerville, OH

Recruiting

TriHealth Cancer Institute (Westside)

White Oak, OH

Recruiting

Mount Carmel Health Center (East)

Whitehall, OH

Recruiting

Genesis HealthCare System

Zanesville, OH

Recruiting

Oklahoma

Mercy Hospital Oklahoma City

Oklahoma City, OK

Recruiting

Oregon

Clackamas Radiation Oncology Center

Clackamas, OR

Recruiting

Bay Area Hospital

Coos Bay, OR

Recruiting

Providence Newberg Medical Center

Newberg, OR

Recruiting

Oregon Health and Science University (OHSU) Knight Cancer Institute

Portland, OR

Recruiting

Pennsylvania

Lehigh Valley Health Network Cancer Institute

Allentown, PA

Recruiting

Christiana Care Health System-Concord Health Center

Chadds Ford, PA

Recruiting

Tower Health Reading Hospital

West Reading, PA

Recruiting

Rhode Island

Smilow Cancer Hospital Care Center

Westerly, RI

Recruiting

South Carolina

Ralph H Johnson VA Medical Center VA Charleston

Charleston, SC

Recruiting

Medical University of South Carolina

Charleston, SC

Recruiting

Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma

Overview

Am I Eligible?

US Trial Locations