Multiple Myeloma Support + Trials

What's the purpose of this trial?

This trial is testing GSK2857916 (Belantamab Mafodotin) with two different of Standard of Care (SoC) regimens; Lenalidomide + Dexamethasone or Bortezomib + Dexamethasone. Researchers are testing which dose and schedule is the safest and works best to treat your cancer.

This trial is currently open and accepting patients.

What's being studied?

Belantamab Mafodotin (formerly GSK2857916) is an investigational product that acts as an antibody-drug conjugate (ADC) with anti-BCMA antibody that binds to BCMA on tumor cell surfaces causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity (ADCC).
Bortezomib is a type of cancer drug called a proteasome inhibitor that interferes with the growth and spread of cancer cells in the body.
Dexamethasone is a steroid given in conjunction with some cancer treatments.
Lenalidomide is an immunomodulatory drug that may help the immune system kill cancer cells. It may also prevent the growth of new blood vessels that tumors need to grow.

What will happen during the trial?

This trial is being run in two phases:

Part 1: Dose Escalation (Phase 1) - Researchers in this phase are trying to determine the highest dose of GSK2857916 that can be tolerated with the least side effects. Patients in this part of the trial will be assigned into two different arms and receive increasing doses of GSK2857916 in combination with Standard of Care drugs.

ARM A: GSK2857916, Lenalidomide and Dexamethasone
- Patients will receive study drugs over a 28 day cycle, with GSK2857916 on day 1, Lenalidomide daily on days 1-21, and dexamethasone weekly. If this initial dose of GSK2857916 is tolerated by at least 3 patients, a second group will receive this same protocol with a higher dose of GSK2857916.
  - SINGLE DOSE - Patients will receive GSK2857916 (100% dose) on day 1, Lenalidomide on days 1-21, and Dexamethasone weekly.
  - SPLIT DOSE - Patients will receive GSK2857916 (50%) dose on days 1 and 8, Lenalidomide on days 1-21, and Dexamethasone weekly.
- Once safety is established for a dose of GSK2857916, , a larger group of patients will be enrolled and Part 2, Dose Expansion will begin with a separate group of patients.
ARM B: GSK2857916, Bortezomib and Dexamethasone
- Patients will receive study drugs over a 21 day cycle, with GSK2857916 on day 1, and Bortezomib and Dexamethasone every few days doing the first half of the cycle. Patients in this group will also receive Acyclovir for eight cycles. If this initial dose of GSK2857916 is tolerated by at least 3 patients, a second group will receive this same protocol with a higher dose of GSK2857916.
- Once safety is established dose of GSK2857916, a larger group of patients will be enrolled and Part 2, Dose Expansion will begin with a separate group of patients. Note: Part 1 is closed for Arm B and Part 2 is Open.

Part 2: Dose Expansion (Phase 2) - Researchers in this part are testing the safety and effects of GSK2857916 in a larger group of patients. Patients in this part of the study will also be separated into two arms and each arm will receive GSK2857916 (as either a single or split dose) in combination with the Standard of Care drugs.

ARM A: GSK2857916, Lenalidomide and Dexamethasone
- Patients will receive GSK2857916 as either a single or split dose with Lenalidomide daily on days 1-21, and Dexamethasone weekly in a 28 day cycle.
- SINGLE DOSE - Patients will receive GSK2857916 (100% dose) on day 1, Lenalidomide on days 1-21, and Dexamethasone weekly.
- SPLIT DOSE - Patients will receive GSK2857916 (50%) dose on days 1 and 8, Lenalidomide on days 1-21, and Dexamethasone weekly.
ARM B: GSK2857916, Bortezomib and Dexamethasone
- Patients will receive GSK2857916 as either a single or split dose with Bortezomib and Dexamethasone in a 21-day cycle.
- SINGLE DOSE- Patients will receive GSK2857916 (100% dose) on day 1, and Bortezomib and Dexamethasone every few days doing the first half of the cycle. Patients in this group will also receive Acyclovir for eight cycles.
- SPLIT DOSE - Patients will receive GSK2857916 (50%) dose on days 1 and 8, and Bortezomib and Dexamethasone every few days doing the first half of the cycle. Patients in this group will also receive Acyclovir for eight cycles.

The arm you’re assigned is determined by you and your doctor. However, this trial is non-randomized, and sequentially assigned, which means that the dose level and dosing schedule (single or split) you are placed in will be determined by when you join the study.

This trial is open label, which means that both you and the researchers running the study will know which group you are placed in, and the dose of the study drugs you are receiving.

During the first 4 doses of GSK2857916, you will also need to visit an opthalmologist (eye doctor) every 3 to weeks for eye examinations depending on your study arm. These visits may continue at the same frequency after the first 4 doses if you have certain side effects in your eyes; but if you don’t have side effects in your eyes, these exams can be reduced to once every 12 weeks.

You may be in the study as long as you are receiving benefit without intolerable side effects from treatment with GSK2857916, unless you decide to stop participating in the study or the study ends.

This trial is being run in two phases:

Part 1: Dose Escalation (Phase 1) - Researchers in this phase are trying to determine the highest dose of GSK2857916 that can be tolerated with the least side effects. Patients in this part of the trial will be assigned into two different arms and receive increasing doses of GSK2857916 in combination with Standard of Care drugs.
- ARM A: GSK2857916, Lenalidomide and Dexamethasone
  - Patients will receive study drugs over a 28 day cycle, with GSK2857916 on day 1, Lenalidomide daily on days 1-21, and dexamethasone weekly. If this initial dose of GSK2857916 is tolerated by at least 3 patients, a second group will receive this same protocol with a higher dose of GSK2857916.
    - SINGLE DOSE - Patients will receive GSK2857916 (100% dose) on day 1, Lenalidomide on days 1-21, and Dexamethasone weekly.
    - SPLIT DOSE - Patients will receive GSK2857916 (50%) dose on days 1 and 8, Lenalidomide on days 1-21, and Dexamethasone weekly.
  - Once safety is established for a dose of GSK2857916, , a larger group of patients will be enrolled and Part 2, Dose Expansion will begin with a separate group of patients.
- ARM B: GSK2857916, Bortezomib and Dexamethasone
  - Patients will receive study drugs over a 21 day cycle, with GSK2857916 on day 1, and Bortezomib and Dexamethasone every few days doing the first half of the cycle. Patients in this group will also receive Acyclovir for eight cycles. If this initial dose of GSK2857916 is tolerated by at least 3 patients, a second group will receive this same protocol with a higher dose of GSK2857916.
  - Once safety is established dose of GSK2857916, a larger group of patients will be enrolled and Part 2, Dose Expansion will begin with a separate group of patients. Note: Part 1 is closed for Arm B and Part 2 is Open.
Part 2: Dose Expansion (Phase 2) - Researchers in this part are testing the safety and effects of GSK2857916 in a larger group of patients. Patients in this part of the study will also be separated into two arms and each arm will receive GSK2857916 (as either a single or split dose) in combination with the Standard of Care drugs.
- ARM A: GSK2857916, Lenalidomide and Dexamethasone
  - Patients will receive GSK2857916 as either a single or split dose with Lenalidomide daily on days 1-21, and Dexamethasone weekly in a 28 day cycle.
  - SINGLE DOSE - Patients will receive GSK2857916 (100% dose) on day 1, Lenalidomide on days 1-21, and Dexamethasone weekly.
  - SPLIT DOSE - Patients will receive GSK2857916 (50%) dose on days 1 and 8, Lenalidomide on days 1-21, and Dexamethasone weekly.
- ARM B: GSK2857916, Bortezomib and Dexamethasone
  - Patients will receive GSK2857916 as either a single or split dose with Bortezomib and Dexamethasone in a 21-day cycle.
  - SINGLE DOSE- Patients will receive GSK2857916 (100% dose) on day 1, and Bortezomib and Dexamethasone every few days doing the first half of the cycle. Patients in this group will also receive Acyclovir for eight cycles.
  - SPLIT DOSE - Patients will receive GSK2857916 (50%) dose on days 1 and 8, and Bortezomib and Dexamethasone every few days doing the first half of the cycle. Patients in this group will also receive Acyclovir for eight cycles.
The arm you’re assigned is determined by you and your doctor. However, this trial is non-randomized, and sequentially assigned, which means that the dose level and dosing schedule (single or split) you are placed in will be determined by when you join the study.

This trial is open label, which means that both you and the researchers running the study will know which group you are placed in, and the dose of the study drugs you are receiving.

During the first 4 doses of GSK2857916, you will also need to visit an ophthalmologist (eye doctor) every 3 to weeks for eye examinations depending on your study arm. These visits may continue at the same frequency after the first 4 doses if you have certain side effects in your eyes; but if you don’t have side effects in your eyes, these exams can be reduced to once every 12 weeks.

You may be in the study as long as you are receiving benefit without intolerable side effects from treatment with GSK2857916, unless you decide to stop participating in the study or the study ends.

See if you qualify

Additional Trial Information

Phase 1/2

Enrollment: 152 patients (estimated)

Need Help?

Interested in joining or learning more about this trial?

(888) 828-2206

I'm Interested

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.

Have been diagnosed with relapsed/refractory multiple myeloma
Have already received an autologous stem cell transplant, or been told that you aren’t eligible for one
Have already received at least one line of therapy for your myeloma

View Additional Criteria

Inclusion Criteria:

Capable of giving signed informed consent.
Male or female, 18 years or older (at the time consent is obtained).
Have confirmed diagnosis of Multiple Myeloma (MM) as defined by the IMWG.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 for Arm A and 0 to 2 for Arm B.
Have undergone stem cell transplant (SCT), or are considered transplant ineligible.
Have been previously treated with at least 1 prior line of MM therapy, and must have documented disease progression during or after their most recent therapy according to the IMWG criteria.
Must have at least ONE aspect of measurable disease, defined as one the following: Urine M-protein excretion >=200 milligram (mg)/24 hours, or; Serum M-protein concentration >=0.5 gram (g)/deciliter (dL) (>=5.0 g/Liter), or; Serum free light chain (FLC) assay: involved FLC level >=10 mg/dL (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
Participants with a history of autologous SCT, are eligible for study participation provided the following eligibility criteria are met: Autologous SCT was >100 days prior to study enrollment; No active bacterial, viral, or fungal infection(s) present; Participant meets the remainder of the eligibility criteria.
All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 4.03, 2010) must be <= Grade 1 at the time of enrollment, except for alopecia. Participants with Grade 2 neuropathy can be enrolled into Len/Dex treatment arm, but not into Bor/Dex treatment arm.
Adequate organ system functions as defined by the laboratory assessments.
The contraception's used by female participant's be consistent with local regulations, regarding methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of child bearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the intervention period and for at least 120 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. WOCBP must have 2 negative highly sensitive serum pregnancy tests, as required by local regulations (first within 14 days of Cycle 1 Day 1 and the second one within 24 hours of dosing on Cycle1 Day1) and agree to use effective contraception during the study and for 120 days after the last dose of study medication; Additional requirements for pregnancy testing during and after study intervention (i.e., REMS program for WOCBP taking lenalidomide).The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Male participant's using contraception should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Male participants must agree to refrain from donating sperm and either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent from the time of first dose of study until 140 days after the last dose of study treatment to allow for clearance of any altered sperm: OR Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year when having sexual intercourse with a WOCBP who is not currently pregnant. If the female partner of the male participant is pregnant at the time of enrollment, or becomes pregnant during the trial, the male participant must agree to remain abstinent (if it is consistent with their preferred and usual lifestyle) or use a male condom. Additional criteria WOCBP participants in Arm A: Due to lenalidomide being a thalidomide analogue with risk for embryofetal toxicity and prescribed under a restricted distribution program called the REVLIMID (Lenalidomide) REMS program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with lenalidomide, during therapy, during dose interruptions and continuing for 120 days following discontinuation of treatment.

Exclusion Criteria:

Systemic anti-myeloma therapy (including systemic steroids) within 14 days, or plasmapheresis within 7 days prior to the first dose of study drug.
Use of an investigational drug within 14 days or five half-lives (whichever is longer) preceding the first dose of study drug.
Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs.
Prior allogenic stem cell transplant. Note: participants who have undergone syngeneic transplant will be allowed only if they have no history and no currently active, graft versus host disease (GvHD) - Evidence of active mucosal or internal bleeding.
Any major surgery within the last four weeks.
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect participant's safety). Participants with isolated proteinuria resulting from MM are eligible, provided they fulfill criteria.
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, or otherwise stable chronic liver disease per investigator's assessment).
Participants with invasive malignancies other than multiple myeloma are excluded, unless the second malignancy has been considered medically stable for at least 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease.Note: Participants with curatively treated non-melanoma skin cancer are allowed without a 2-year restriction.
Evidence of cardiovascular risk including any of the following: a. Corrected QT (QTc) interval >=480 millisecond (msec); Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block; History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 3 months of Screening; Class III or IV heart failure as defined by the New York Heart Association functional classification system; Uncontrolled hypertension.
Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to GSK2857916, or any of the components of the study treatment.
Pregnant or lactating female.
Active infection requiring treatment.
Known HIV infection.
Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb at Screening or within 3 months prior to first dose of study treatment).
Current corneal disease except for mild punctuate keratopathy.
Positive hepatitis C antibody test result or positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study treatment. NOTE: Participants with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C ribonucleic acid (RNA) test is obtained.
Current corneal disease except for mild punctuate keratopathy.
Additional Exclusion Criteria for participants Assigned to Treatment A: Participants unable to tolerate antithrombotic prophylaxis must be excluded; Discontinuation of prior treatment with lenalidomide due to intolerable AEs.
Additional Exclusion Criteria for Participants Assigned to Treatment B: Unacceptable AEs from previous bortezomib treatment; Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain from previous bortezomib treatment; Intolerance or contraindications to anti-viral prophylaxis.

DREAMM-6 Data Set the Stage for Further Study of Belantamab Mafodotin–Based Triplet in Myeloma

December 05, 2020

For the 18 patients receiving 2.5 mg/kg of belamaf every 3 weeks with standard-of-care bortezomib and dexamethasone, there was an overall response rate (ORR) of 78% (95% CI, 52.4%-93.6%), with very good partial response in 9 patients (50%) and partial response in 5 patients (28%). Minimal response was observed in 1 patient and 3 patients (17%) had stable disease. There was also a clinical benefit rate of 83% (95% CI, 58.6%-96.4%). The median duration of response was not reached at a median of 18.2 weeks (range, 6.0-46.4) of treatment.

Of the patients with prior exposure to bortezomib, the ORR was 75%, and those with exposure to daratumumab (Darzalex) had an ORR of 67%; the clinical benefit rates were 81% and 67%, respectively.

Response rates increased for those treated in earlier lines of therapy. The ORR was 100% for patients treated in the second line compared with 50% for those who had received more than 3 prior lines of therapy.

All of the patients on the trial had treatment-related adverse events (AEs), although there were no new safety signals to date. Grade 3/4 AEs were seen in 16 patients (89%) and treatment-related serious AEs were seen in 5 (28%). No patients had any grade 5 AEs of interest. Serious AEs were reported in 67% and were considered related to treatment in 28%.

GSK gives taste of data on multiple myeloma drug ahead of ASCO

May 27, 2020

DREAMM-6 is testing belantamab mafodotin in combination with bortezomib and dexamethasone, in patients with relapsed or refractory myeloma who have received at least one prior therapy.
The data showed that the combination produced an overall response rate of 78% among 18 patients, including 50% who received a very good partial response and 28% who achieved a partial response.
After 18.2 weeks of treatment, the median duration of response had not yet been reached.

What's the purpose of this trial?

What's being studied?

What will happen during the trial?

Additional Trial Information

You may be able to join this trial if you:

Published Results

DREAMM-6 Data Set the Stage for Further Study of Belantamab Mafodotin–Based Triplet in Myeloma

GSK gives taste of data on multiple myeloma drug ahead of ASCO

Trial Locations

All Trial Locations

Arizona

Cancer Treatment Centers of America Western Regional Medical Center Goodyear, AZ

Open and Accepting

Georgia

Winship Cancer Institute of Emory University Atlanta, GA

Open and Accepting

Indiana

IU Simon Cancer Center Indiana University Indianapolis, IN

Open and Accepting

Michigan

Michigan State University (Breslin Cancer Center) Lansing, MI

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus St. Louis, MO

Open and Accepting

Nebraska

CHI Health Saint Francis Medical Center Grand Island, NE

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health Hackensack, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center New York, NY

Open and Accepting

North Shore Hematology Oncology Associates, P.C East Setauket, NY

Open and Accepting

South Carolina

Prisma Health Greenville Memorial Hospital Greenville, SC

Open and Accepting

Texas

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health Dallas, TX

Open and Accepting

Mary Crowley Cancer Research Centers Dallas, TX

Open and Accepting

Trial Resources

Trial Links

Cancer Treatment Centers of America Western Regional Medical Center
Goodyear, AZ

Winship Cancer Institute of Emory University
Atlanta, GA

IU Simon Cancer Center Indiana University
Indianapolis, IN

Michigan State University (Breslin Cancer Center)
Lansing, MI

Alvin J. Siteman Cancer Center Washington University Medical Campus
St. Louis, MO

CHI Health Saint Francis Medical Center
Grand Island, NE

John Theurer Cancer Center Hackensack Meridian Health
Hackensack, NJ

Memorial Sloan Kettering Cancer Center
New York, NY

North Shore Hematology Oncology Associates, P.C
East Setauket, NY

Prisma Health Greenville Memorial Hospital
Greenville, SC

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health
Dallas, TX

Mary Crowley Cancer Research Centers
Dallas, TX