Phase 1b/2a Study to Evaluate CC-92480 (BMS-986348) in Combination with Other Treatments in Relapsed or Refractory Multiple Myeloma
- Conditions
- Relapsed or Refractory Multiple Myeloma (RRMM)MedDRA version: 21.1Level: LLTClassification code: 10067095Term: Multiple myeloma progression Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-509384-25-00
- Lead Sponsor
- Celgene Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Signed written informed consent prior to any study procedure., = 18 years of age the time of signing the ICF., Relapsed or refractory multiple myeloma (MM) and must: a. have documented disease progression during or after their last myeloma therapy b. be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM, Must have measurable disease., Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1., Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP)
Known active or history of central nervous system (CNS) involvement of MM., COVID-19 vaccine within 14 days prior to C1D1, Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis., Impaired cardiac function or clinically significant cardiac disease., Participant has previous SARS-CoV-2 infection within 14 days for asymptomatic or mild symptomatic infections or 28 days for severe/critical illness prior to Cycle 1 Day 1 (C1D1), For Part 1: received prior therapy with CC-92480., For Part 2: received prior therapy with CC-92480, tazemetostat, BMS- 986158, or trametinib., Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment, Received any of the following within 14 days prior to initiating study treatment: a. Plasmapheresis b. Major surgery c. Radiation therapy other than local therapy for myeloma associated bone lesions d. Use of any systemic anti-myeloma drug therapy, Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the safety and tolerability of CC-92480 and dexamethasone in combination with tazemetostat, BMS-986158, or trametinib in participants with RRMM.<br>To define the RP2D and schedule of each combination in participants with RRMM.;Secondary Objective: To evaluate the preliminary efficacy of CC-92480 in novel combinations compared against control (CC-92480 + dexamethasone) in participants with RRMM., To characterize the pharmacokinetics of CC-92480 when administered in combination with tazemetostat, BMS-986158, or trametinib.;Primary end point(s): Safety : Type, frequency, seriousness, and severity of adverse events (AEs), and relationship of AEs to study treatment., Recommended Phase 2 Dose (RP2D): Establish the RP2D for CC-92480 in each novel treatment combination with dexamethasone.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Overall Response Rate (ORR) : Best response = partial response (PR), according to the International Myeloma Working Group (IMWG) Uniform Response Criteria89;Secondary end point(s):Complete Response Rate (CRR): Percentage of participants who achieved = complete response (CR), according to IMWG Uniform Response Criteria;Secondary end point(s):Very Good Partial Response Rate (VGPRR) : Percentage of participants who achieved = VGPR, according to IMWG Response Criteria;Secondary end point(s):Progression-Free Survival (PFS) : Time from enrollment to the first documentation of progressive disease (PD) or death from any cause during study, whichever occurs earlier;Secondary end point(s):Time-to-Response (TTR) : Time from first dose to the first documentation of response (= PR);Secondary end point(s):Duration of Response (DOR) : Time from the first documentation of response (= PR) to the first documentation of PD or death