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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

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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: CC-92480 Drug: Tazemetostat Drug: BMS-986158 Drug: Trametinib Drug: Dexamethasone Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 18, 2022
Estimated Primary Completion Date : October 12, 2026
Estimated Study Completion Date : October 12, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1 Arm A: Dose Finding Drug: CC-92480
Specified dose on specified days
Other Name: BMS-986348

Drug: Tazemetostat
Specified dose on specified days

Drug: Dexamethasone
Specified dose on specified days
Experimental: Part 1 Arm B: Dose Finding Drug: CC-92480
Specified dose on specified days
Other Name: BMS-986348

Drug: BMS-986158
Specified dose on specified days

Drug: Dexamethasone
Specified dose on specified days
Experimental: Part 1 Arm C: Dose Finding Drug: CC-92480
Specified dose on specified days
Other Name: BMS-986348

Drug: Trametinib
Specified dose on specified days

Drug: Dexamethasone
Specified dose on specified days
Active Comparator: Part 2 Arm D: Dose Expansion Drug: CC-92480
Specified dose on specified days
Other Name: BMS-986348

Drug: Dexamethasone
Specified dose on specified days
Experimental: Part 2 Arm E: Dose Expansion Drug: CC-92480
Specified dose on specified days
Other Name: BMS-986348

Drug: Tazemetostat
Specified dose on specified days

Drug: Dexamethasone
Specified dose on specified days
Experimental: Part 2 Arm F: Dose Expansion Drug: CC-92480
Specified dose on specified days
Other Name: BMS-986348

Drug: BMS-986158
Specified dose on specified days

Drug: Dexamethasone
Specified dose on specified days
Experimental: Part 2 Arm G: Dose Expansion Drug: CC-92480
Specified dose on specified days
Other Name: BMS-986348

Drug: Trametinib
Specified dose on specified days

Drug: Dexamethasone
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Establish recommended Phase 2 dose (RP2D) [ Time Frame: Up to approximately 2 years ]
  3. Establish dosing schedule of each combination for Part 2 Dose Expansion [ Time Frame: Up to approximately 2 years ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Up to approximately 4 years ]
  2. Very good partial response rate (VGPRR) [ Time Frame: Up to approximately 4 years ]
  3. Complete response rate (CRR) [ Time Frame: Up to approximately 4 years ]
  4. Time-to-response (TTR) [ Time Frame: Up to approximately 4 years ]
  5. Duration of response (DOR) [ Time Frame: Up to approximately 4 years ]
  6. Progression-free survival (PFS) [ Time Frame: Up to approximately 4 years ]
  7. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to approximately 28 days ]
  8. Time to maximum plasma concentration (Tmax) [ Time Frame: Up to approximately 28 days ]
  9. Area under the concentration-time curve (AUC) [ Time Frame: Up to approximately 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05372354


Contacts
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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 #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05372354    
Other Study ID Numbers: CA057-003
2021-005167-51 ( EudraCT Number )
U1111-1269-5704 ( Registry Identifier: WHO )
First Posted: May 12, 2022    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
BMS-986348
CC-92480
BMS-986158
 Dexamethasone
Tazemetostat
Trametinib
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
 Trametinib
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action