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NCT Number: NCT05372354

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 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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Alberta Health Services AHS - Foothills Medical Centre FMC, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Relapsed or refractory multiple myeloma (MM) and must:
  • Have documented disease progression during or after their last myeloma therapy.
  • For Part 1 Dose Finding: Be refractory to, intolerant to, or not a candidate for available, established therapies known to provide clinical benefit in MM; For Part 2 Dose Expansion: Be refractory to or have relapsed after the protocol specified number of prior lines of therapy that include an immunomodulatory drug (IMiD), a proteasome inhibitor, an anti-CD38 mAb, and a T-cell redirecting therapy (TRT, eg, a CAR-T or T-cell engaging bispecific treatment) unless the participant is not a candidate for TRT.
  • 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:
  • Plasmapheresis
  • Major surgery
  • Radiation therapy other than local therapy for myeloma associated bone lesions
  • 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

Treatment and study plan

CC-92480

Drug

Specified dose on specified days

Other names: BMS-986348

Tazemetostat

Drug

Specified dose on specified days

BMS-986158

Drug

Specified dose on specified days

Trametinib

Drug

Specified dose on specified days

Dexamethasone

Drug

Specified dose on specified days

Primary outcomes

  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. Number of participants with Serious AEs

    Time frame: Up to approximately 4 years

  3. Number of participants with AEs meeting protocol-defined DLT criteria

    Time frame: Up to approximately 4 years

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to approximately 4 years

  5. Number of deaths

    Time frame: Up to approximately 4 years

  6. Establish recommended Phase 2 dose (RP2D)

    Time frame: Up to approximately 2 years

  7. Establish dosing schedule of each combination for Part 2 Dose Expansion

    Time frame: Up to approximately 2 years

Secondary outcomes

  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

  10. Terminal Half-Life (T-Half)

    Time frame: Up to approximately 28 days

  11. Apparent total body clearance (CLT/F)

    Time frame: Up to approximately 28 days

  12. Apparent volume of distribution (Vz/F)

    Time frame: Up to approximately 28 days

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

[email protected]

855-907-3286

First line of email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 12, 2022
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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