A Study to Evaluate Safety, Drug Levels and Effectiveness of CC-92480 (BMS-986348) in Combination With Other Treatments in Participants With Relapsed or Refractory Multiple Myeloma
*The trial information contained on this page was imported from ClinicalTrials.gov. Click here to view this trial on ClinicalTrials.gov.
- Full Title:
- An Exploratory Phase 1b/2a Multicenter, Open-Label, Novel-Novel Combination Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CC-92480 (BMS-986348) in Novel Therapeutic Combinations in Participants With Relapsed or Refractory Multiple Myeloma
- Myeloma stage or condition:
- Multiple Myeloma
- Study phase:
- Phase 1/Phase 2
- Summary/Purpose:
- The purpose of this study is to assess the safety, tolerability and preliminary effectiveness of CC-92480 (BMS-986348) in novel therapeutic combinations for the treatment of Relapsed or Refractory Multiple Myeloma (RRMM).
- Detailed Description:
- Not available
- Treatments:
- Drug : CC-92480
Specified dose on specified days
- Drug : Tazemetostat
Specified dose on specified days
- Drug : BMS-986158
Specified dose on specified days
- Drug : Trametinib
Specified dose on specified days
- Drug : Dexamethasone
Specified dose on specified days
- Study Arms:
- Experimental : Part 1 Arm A: Dose Finding
- Experimental : Part 1 Arm B: Dose Finding
- Experimental : Part 1 Arm C: Dose Finding
- Active Comparator : Part 2 Arm D: Dose Expansion
- Experimental : Part 2 Arm E: Dose Expansion
- Experimental : Part 2 Arm F: Dose Expansion
- Experimental : Part 2 Arm G: Dose Expansion
- Study Type:
- Interventional
- Study Design:
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Recruitment status:
- Recruiting
- Eligibility criteria:
-
Inclusion Criteria:
- Relapsed or refractory multiple myeloma (MM) and must: 1. have documented disease progression during or after their last myeloma therapy 2. 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
- 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
- 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: 1. Plasmapheresis 2. Major surgery 3. Radiation therapy other than local therapy for myeloma associated bone lesions 4. 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
- COVID-19 vaccine within 14 days prior to C1D1 Other protocol-defined inclusion/exclusion criteria apply
- Locations / Centres:
-
Alberta Health Services AHS - Foothills Medical Centre FMC, Calgary, Alberta – Recruiting
University of Alberta - Cross Cancer Institute, Edmonton, Alberta – Recruiting
University Health Network UHN - Princess Margaret Hospital PMH, Toronto, Ontario – Recruiting
- Contacts:
- Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone: 855-907-3286
Email: [email protected]
- Publications:
- ???
- First posted:
- 2022-05-12
- Actual start date:
- October 18, 2022
- Last updated:
- 2024-02-26
- Estimated enrollment:
- 220
- Estimated completion date:
- 2026-10-12
- Estimated primary completion date:
- 2026-10-12
- Condition:
- Multiple Myeloma
- Gender:
- All
- Ages:
- 18 Years-N/A
- Accepts healthy volunteers:
- No
- Listed location countries:
- Canada
- Norway
- Spain
- United Kingdom
- United States
- NCT number:
- NCT05372354
- Other study ID numbers:
- CA057-003
- Has Data monitoring committee:
- No
- U.S. FDA-regulated product:
- Yes
- IPD Sharing Statement :
- ???
- Responsible party:
-
Sponsor
- Study sponsor:
- lead_sponsor
Bristol-Myers Squibb
Industry
- Collaborators:
- ???
- Investigators:
- Bristol-Myers Squibb Bristol-Myers Squibb
- Protocol Registration and Results System:
- ???
- Verification date:
- 2024-02-01