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Phase 1b/2a Study to Evaluate CC-92480 (BMS-986348) in Combination with Other Treatments in Relapsed or Refractory Multiple Myeloma
EU CTIS ID: 2023-509384-25-00
What this study is testing
To determine the safety and tolerability of CC-92480 and dexamethasone in combination with tazemetostat, BMS-986158, or trametinib in participants with RRMM. To define the RP2D and schedule of each combination in participants with RRMM.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed written informed consent prior to any study procedure.
- ≥ 18 years of age the time of signing the ICF.
- Relapsed or refractory multiple myeloma (MM) and must: a. have documented disease progression during or after their last myeloma therapy. b. For part I 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 at least 2 prior lines of therapy that include an 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)
You likely can't join if
- Known active or history of central nervous system (CNS) involvement of MM.
- COVID-19 vaccine within 14 days prior to C1D1
- 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.
- For Part 1: received prior therapy with CC-92480.
- For Part 2: received prior therapy with CC-92480, tazemetostat, BMS- 986158, or trametinib.
See the full eligibility criteria
- Signed written informed consent prior to any study procedure.
- ≥ 18 years of age the time of signing the ICF.
- Relapsed or refractory multiple myeloma (MM) and must: a. have documented disease progression during or after their last myeloma therapy. b. For part I 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 at least 2 prior lines of therapy that include an 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)
- Known active or history of central nervous system (CNS) involvement of MM.
- COVID-19 vaccine within 14 days prior to C1D1
- 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.
- 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: a. Plasmapheresis b. Major surgery c. Radiation therapy other than local therapy for myeloma associated bone lesions d. 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.