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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05372354
Recruitment Status : Recruiting
First Posted : May 12, 2022
Last Update Posted : February 28, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 6, 2022
First Posted Date  ICMJE May 12, 2022
Last Update Posted Date February 28, 2024
Actual Study Start Date  ICMJE October 18, 2022
Estimated Primary Completion Date October 12, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2022)
  • Number of participants with adverse events (AEs) [ Time Frame: From first participant first visit until 28 days after the last participant discontinues study treatment, up to approximately 4 years ]
  • Establish recommended Phase 2 dose (RP2D) [ Time Frame: Up to approximately 2 years ]
  • Establish dosing schedule of each combination for Part 2 Dose Expansion [ Time Frame: Up to approximately 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2022)
  • Overall response rate (ORR) [ Time Frame: Up to approximately 4 years ]
  • Very good partial response rate (VGPRR) [ Time Frame: Up to approximately 4 years ]
  • Complete response rate (CRR) [ Time Frame: Up to approximately 4 years ]
  • Time-to-response (TTR) [ Time Frame: Up to approximately 4 years ]
  • Duration of response (DOR) [ Time Frame: Up to approximately 4 years ]
  • Progression-free survival (PFS) [ Time Frame: Up to approximately 4 years ]
  • Maximum observed plasma concentration (Cmax) [ Time Frame: Up to approximately 28 days ]
  • Time to maximum plasma concentration (Tmax) [ Time Frame: Up to approximately 28 days ]
  • Area under the concentration-time curve (AUC) [ Time Frame: Up to approximately 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary 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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: CC-92480
    Specified dose on specified days
    Other Name: BMS-986348
  • 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  ICMJE
  • Experimental: Part 1 Arm A: Dose Finding
    Interventions:
    • Drug: CC-92480
    • Drug: Tazemetostat
    • Drug: Dexamethasone
  • Experimental: Part 1 Arm B: Dose Finding
    Interventions:
    • Drug: CC-92480
    • Drug: BMS-986158
    • Drug: Dexamethasone
  • Experimental: Part 1 Arm C: Dose Finding
    Interventions:
    • Drug: CC-92480
    • Drug: Trametinib
    • Drug: Dexamethasone
  • Active Comparator: Part 2 Arm D: Dose Expansion
    Interventions:
    • Drug: CC-92480
    • Drug: Dexamethasone
  • Experimental: Part 2 Arm E: Dose Expansion
    Interventions:
    • Drug: CC-92480
    • Drug: Tazemetostat
    • Drug: Dexamethasone
  • Experimental: Part 2 Arm F: Dose Expansion
    Interventions:
    • Drug: CC-92480
    • Drug: BMS-986158
    • Drug: Dexamethasone
  • Experimental: Part 2 Arm G: Dose Expansion
    Interventions:
    • Drug: CC-92480
    • Drug: Trametinib
    • Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2022)		 220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 12, 2026
Estimated Primary Completion Date October 12, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Canada,   Norway,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05372354
Other Study ID Numbers  ICMJE CA057-003
2021-005167-51 ( EudraCT Number )
U1111-1269-5704 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP