A trial to determine the safety and effectiveness of CC-92480 in combination with bortezomib and dexamethasone as compared to pomalidomide in combination with bortezomib and dexamethasone in people who have Multiple Myeloma that is not responsive after treatment or has returned after a period of treatment.
- Conditions
- Relapsed or Refractory Multiple Myeloma (RRMM)MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-001957-30-IT
- Lead Sponsor
- CELGENE CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 950
•Subject has documented diagnosis of MM and measurable disease, defined as:
—M-protein = 0.5 g/dL by serum protein electrophoresis (sPEP), or = 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or,
—For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels > 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio
•Subject has received 1 to 3 prior anti-myeloma lines of therapy
•Subject must have received prior treatment with a lenalidomide containing regimen
•Subject achieved a minimal response [MR] or better to at least 1 prior antimyeloma therapy
•Subject must have documented disease progression during or after their last antimyeloma regimen
•Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 418
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 532
•Subject has had prior treatment with CC-92480 or pomalidomide
•Subject has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor
•Subject discontinued prior treatment with bortezomib due to toxicity
•Any of the following laboratory abnormalities:
—ANC < 1,000/µL (no GCSF allowed within 7 days prior to screening CBC; within 14 prior days for pegfilgrastim)
—Platelet : < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 50,000/µL for subjects in whom = 50% of bone marrow nucleated cells are plasma cells (transfusions are not permitted within 7 days of screening CBC)
—Hemoglobin < 8 g/dL (< 4.9 mmol/L).
—eGFR < 30 mL/min/1.73m2 or requiring dialysis
—Corrected serum calcium > 13.5 mg/dL (> 3.4 mmol/L)
—AST or ALT > 2.5 × ULN
—Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert’s syndrome
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method