The trial is taking place at:
L

Leicester Royal Infirmary | Hope Trials Facility

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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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: Trametinib
Drug: Dexamethasone
Drug: BMS-986158
Drug: CC-92480
Drug: Tazemetostat

Study type

Interventional

Funder types

Industry

Identifiers

NCT05372354
CA057-003
U1111-1269-5704 (Registry Identifier)
2021-005167-51 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

220 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Relapsed or refractory multiple myeloma (MM) and must:

  • have documented disease progression during or after their last myeloma therapy
  • 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:

  • 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

220 participants in 7 patient groups

Part 1 Arm A: Dose Finding
Experimental group
Treatment:
Drug: Tazemetostat
Drug: Dexamethasone
Drug: CC-92480
Part 1 Arm B: Dose Finding
Experimental group
Treatment:
Drug: Dexamethasone
Drug: BMS-986158
Drug: CC-92480
Part 1 Arm C: Dose Finding
Experimental group
Treatment:
Drug: Dexamethasone
Drug: CC-92480
Drug: Trametinib
Part 2 Arm D: Dose Expansion
Active Comparator group
Treatment:
Drug: Dexamethasone
Drug: CC-92480
Part 2 Arm E: Dose Expansion
Experimental group
Treatment:
Drug: Tazemetostat
Drug: Dexamethasone
Drug: CC-92480
Part 2 Arm F: Dose Expansion
Experimental group
Treatment:
Drug: Dexamethasone
Drug: BMS-986158
Drug: CC-92480
Part 2 Arm G: Dose Expansion
Experimental group
Treatment:
Drug: Dexamethasone
Drug: CC-92480
Drug: Trametinib

Trial contacts and locations

18

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Central trial contact

First line of email MUST contain NCT # and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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