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

Subjects assigned to CC-220 monotherapy, who develop progressive disease (PD) will have the option to receive DEX in addition to CC-220 after consultation with the Medical Monitor. The dose of CC-220 will not be higher than the dose of CC-220 used in combination with dexamethasone in Cohort B that has been determined to be safe. Progressive disease must be confirmed in accordance with international myeloma working group (IMWG) criteria.

The starting dose of DEX will be 40 mg for subjects who are ≤75 years of age and 20 mg for subjects who are >75 years of age, given once weekly. This treatment will continue until PD, unacceptable toxicity or the subject withdraws consent.

For Cohorts A and B, the starting dose level of CC-220, dose level 1, is 0.3 mg. A dose level -1, of 0.15 mg, may also be evaluated if the starting dose level of 0.3 mg for 21 days of a 28-day cycle is not tolerated. For Cohorts E and F, the starting dose level of CC-220, dose level 1, is one dose level below the maximum dose for Cohort B that has been determined to be safe by the dose escalation committee (DEC) at the start of enrollment for both cohorts. For Cohort E in addition to CC-220 and DEX, daratumumab will be administered intravenously (IV) at a 16mg/kg dose. For Cohort F in addition to CC-220 and DEX, bortezomib will be administered subcutaneous (SC) at a 1.3mg/m2 dose.

All subjects with a minimal response (MR) or better who discontinue study treatment in Part 1 or Part 2 of the study for a reason other than PD or withdrawal of consent from the study will be followed for response assessment every 28 days (every 21 days for Cohort F) until PD.

The study will be conducted in compliance with the International Council for Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.

The initiation of Part 2 will begin when the RP2D is established in Part 1 in either Cohort A or Cohort B. Either cohort may begin once the RP2D is determined for each cohort independently during Part 1. All expansion decisions will be determined by the DEC after review of all safety, PK, biomarker and preliminary efficacy data, as applicable. During Part 2, the Independent Expert Reviewer will review safety data and any other data deemed relevant so that subject safety is ensured.

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:

  1. Subjects must have a documented diagnosis of Multiple Myeloma and have measurable disease defined as:

    • M-protein (serum and/or urine protein electrophoresis (sPEP or uPEP)): sPEP ≥0.5 g/dL or uPEP ≥200 mg/24 hours and/or
    • Light chain Multiple Myeloma without measurable disease in the serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
  2. All subjects must have documented disease progression on or within 60 days from the last dose of their last myeloma therapy
  3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2

Exclusion Criteria:

  1. Subject has nonsecretory or oligosecretory multiple myeloma
  2. Subjects with Plasma Cell leukemia or amyloidosis
  3. Any of the following laboratory abnormalities
    • Absolute neutrophil count (ANC) <1,000/μL
    • 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 ([CrCl] <50 mL/min) or requiring dialysis would be excluded
  4. Subjects with peripheral neuropathy ≥Grade 2

US Trial Locations

Accepting Patients

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

Verified Winship Cancer Institute of Emory University -
Verified John Theurer Cancer Center - Hackensack Meridian Health

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Not Currently Accepting Patients

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

NYU Winthrop Hospital

Mineola, NY

NewYork-Presbyterian/ Weill Cornell Medical Center

New York, NY

University of Rochester Medical Center - James P. Wilmot Cancer Center

Rochester, NY

Prisma Health

Greenville, SC

University of Texas Southwest Medical Center (Dallas)

Dallas, TX

Arizona
Arkansas
Georgia
Verified Winship Cancer Institute of Emory University -

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

Illinois
Kansas
Maryland
Massachusetts
Michigan
New Jersey
Verified John Theurer Cancer Center - Hackensack Meridian Health

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

New York
NYU Winthrop Hospital

Mineola, NY

NewYork-Presbyterian/ Weill Cornell Medical Center

New York, NY

University of Rochester Medical Center - James P. Wilmot Cancer Center

Rochester, NY

North Carolina
Ohio
Pennsylvania
South Carolina
Prisma Health

Greenville, SC

Texas
University of Texas Southwest Medical Center (Dallas)

Dallas, TX

Utah
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 be aware that the government website may include information that is inaccurate and/or out-of-date.

Resources

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