A Safety Study to Determine Dose and Tolerability of CC-220 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and Refractory Multiple Myeloma

Overview

This is a multicenter, multicountry, open-label, Phase 1b/2a dose-escalation study to determine the maximum tolerated dose of CC-220 when administered as monotherapy and in combination with dexamethasone. The study will consist of an escalating dose-escalation portion (Part 1) as well as an expansion of each cohort (ie, Cohort C: Monotherapy (MonoT) and Cohort D: Combination treatment with 2 drugs (DoubleT) at the recommended Phase 2 dose (RP2D) to further evaluate safety and estimate preliminary efficacy (Part 2).

SparkCures ID 865
Trial Phase Phase 1/2
Enrollment 303 Patients
Treatments
Trial Sponsors
  • Celgene Corporation
NCT Identifier

NCT02773030

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study:

  1. Subject is ≥18 years of age at the time of signing the informed consent form (ICF)
  2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted
  3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements
  4. Subjects must have a documented diagnosis of Multiple myeloma (MM) and have measurable disease by serum and/or urine protein electrophoresis (sPEP or uPEP): sPEP ≥0.5 g/dL or uPEP, ≥200 mg/24 hours
  5. All subjects must have received at least 2 prior myeloma regimens (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen)
  6. All subjects must have received prior treatment with at least 2 consecutive cycles of a lenalidomide or pomalidomide-containing regimen
  7. All subjects must have received prior treatment with at least 2 consecutive cycles of a proteasome inhibitor or a proteasome inhibitor-containing regimen
  8. All subjects must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy
  9. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
  10. Females of childbearing potential (FCBP) must:
    1. Have a negative pregnancy test as verified by the Investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after the end of IP. This applies even if the subject practices true abstinence* from heterosexual contact.
    2. Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use two forms of reliable contraception. One must be a highly effective method and one additional effective (barrier) method. Contraception must be practiced without interruption, 28 days prior to initiation of CC-220, during the study therapy (including dose interruptions), and for at least 28 days after discontinuation of study therapy.
  11. Male subjects must: a. Practice true abstinence* (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following investigational product discontinuation, even if he has undergone a successful vasectomy. * True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.]
  12. Males must agree to refrain from donating sperm while on CC-220 and for 90 days after discontinuation from Investigational product (IP).
  13. All subjects must agree to refrain from donating blood while on IP and for 90 days after discontinuation from IP
  14. All male and female subjects must follow all requirements defined in the Pregnancy Prevention Program.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

  1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
  2. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
  3. Subject has any condition that confounds the ability to interpret data from the study
  4. Subject has nonsecretory or oligosecretory multiple myeloma
  5. Subjects with Plasma Cell leukemia
  6. Any of the following laboratory abnormalities
    • Absolute neutrophil count (ANC) <1,000/μL
    • Hemoglobin <8 g/dL (<4.9 mmol/L)
    • Platelet count <75,000/μL Corrected serum calcium >13.5 mg/dL (>3.4 mmol/L)
    • Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)/alanine aminotransferase (ALT) ≥2.0 x upper limit of normal (ULN)
    • Serum total bilirubin and alkaline phosphatase >1.5 x ULN
    • Subjects with serious renal impairment (24-hour creatinine clearance [CrCl] <50 mL/min) or requiring dialysis would be excluded
  7. Subjects with peripheral neuropathy ≥Grade 2
  8. Subjects with gastrointestinal disease that may significantly alter the absorption of CC-220
  9. Subjects with a prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥5 years with the exception of the following noninvasive malignancies:
    • Basal cell carcinoma of the skin
    • Squamous cell carcinoma of the skin
    • Carcinoma in situ of the cervix
    • Carcinoma in situ of the breast
    • Incidental histological findings of prostate cancer such as T1a or T1b using the Tumor/Node/Metastasis (TNM) classification of malignant tumors or prostate cancer that is curative
  10. Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide or DEX
  11. Subject has known or suspected hypersensitivity to the excipients contained in the formulation of CC-220 or DEX
  12. Subject has received any of the following within the last 14 days of initiating IP:
    • Plasmapheresis
    • Major surgery (as defined by the Investigator)
    • Radiation therapy other than local therapy for MM associated bone lesions
    • Use of any systemic myeloma drug therapy
  13. Subject has been treated with an investigational agent within 28 days or 5 half-lives (whichever is longer) of initiating Investigational product (IP)
  14. Subject has any one of the following:
    • Clinically significant abnormal electrocardiogram (ECG) finding at Screening
    • Congestive heart failure (New York Heart Association Class III or IV)
    • Myocardial infarction within 12 months prior to starting IP
    • Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris
  15. Subject has current or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions to this criterion:
    • Intranasal, inhaled, topical or local steroid injections (eg, intra-articular injection)
    • Systemic corticosteroids at physiologic doses that do not exceed 10 mg/day of prednisone or equivalent
    • Steroids as premedication for hypersensitivity reactions (eg, computed tomography [CT] scan premedication)
  16. Subject has taken a strong inhibitor or inducer of CYP3A4/5 at least one week prior to dosing and during the course of study and grapefruit or related products ≤1 week prior to dosing and intends to eat these products throughout the study
  17. Subject known to test positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis A or C
  18. Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis
  19. Subject is a female who is pregnant, nursing or breastfeeding

US Trial Locations

Accepting Patients

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

Not Currently Accepting Patients

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

NewYork-Presbyterian/ Weill Cornell Medical Center

New York, NY

Arizona
Mayo Clinic (Scottsdale)

Scottsdale, AZ

Arkansas
Georgia
Verified Winship Cancer Institute of Emory University<br />

SparkCures Verified Accurate, up-to-date information. Learn more

Kansas
Maryland
Massachusetts
Michigan
New Jersey
Verified John Theurer Cancer Center<br />Hackensack Meridian Health

SparkCures Verified Accurate, up-to-date information. Learn more

New York
NewYork-Presbyterian/ Weill Cornell Medical Center

New York, NY

North Carolina
Ohio
Pennsylvania
International Locations

This trial has active trial locations in countries outside of the United States.

Our system currently only provides clinical trial matching services for myeloma patients in the United States.

You can view this clinical trial's international locations by visiting ClinicalTrials.gov. Please note the information provided through the government website may be inaccurate and/or out-dated.

Resources

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