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
- Primary Purpose: Treatment
- Masking: None
- Recruitment status:
- Recruiting
- Eligibility criteria:
-
usion 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:
- Not available
- Actual start date:
- 2022-10-18
- Last updated:
- 2024-08-08
- Estimated enrollment:
- 220
- Estimated completion date:
- 2026-10-12
- Estimated primary completion date:
- 2026-10-12
- Condition:
- Multiple Myeloma
- Gender:
- All
- Ages:
- 18 Years-
- Accepts healthy volunteers:
- Not available
- Listed location countries:
- Not available
- NCT number:
- NCT05372354
- Other study ID numbers:
- CA057-003
- Has Data monitoring committee:
- Not available
- 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:
- 2024-08-01