MEZIGDOMIDE for Relapsed or refractory multiple myeloma

Inclusion criteria

• {"criterion_text":"- Signed written informed consent prior to any study procedure."}
• {"criterion_text":"- ≥ 18 years of age the time of signing the ICF."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Must have measurable disease."}
• {"criterion_text":"- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1."}
• {"criterion_text":"- Agree to follow the CC-92480 Pregnancy Prevention Plan (PPP)"}

Exclusion criteria

• {"criterion_text":"- Known active or history of central nervous system (CNS) involvement of MM."}
• {"criterion_text":"- COVID-19 vaccine within 14 days prior to C1D1"}
• {"criterion_text":"- Plasma cell leukemia; Waldenstrom's macroglobulinemia; polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS) syndrome; or clinically significant light-chain amyloidosis."}
• {"criterion_text":"- Impaired cardiac function or clinically significant cardiac disease."}
• {"criterion_text":"- For Part 1: received prior therapy with CC-92480."}
• {"criterion_text":"- For Part 2: received prior therapy with CC-92480, tazemetostat, BMS- 986158, or trametinib."}
• {"criterion_text":"- Previously received allogeneic stem-cell transplant at any time or received autologous stem-cell transplant within 12 weeks of initiating study treatment"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Used any investigational agents within 28 days or 5 half-lives (whichever is shorter) prior to initiating study treatment."}

Primary endpoints

• {"endpoint_text":"- Safety : Type, frequency, seriousness, and severity of adverse events (AEs), and relationship of AEs to study treatment.","definition_or_measurement_approach":"As stated: Type, frequency, seriousness, and severity of adverse events (AEs), and relationship of AEs to study treatment."}
• {"endpoint_text":"- Recommended Phase 2 Dose (RP2D): Establish the RP2D for CC-92480 in each novel treatment combination with dexamethasone.","definition_or_measurement_approach":"As stated: Establish the RP2D for CC-92480 in each novel treatment combination with dexamethasone."}

Secondary endpoints

• {"endpoint_text":"- Overall Response Rate (ORR) : Best response ≥ partial response (PR), according to the International Myeloma Working Group (IMWG) Uniform Response Criteria89","definition_or_measurement_approach":"Best response ≥ partial response (PR) according to IMWG Uniform Response Criteria."}
• {"endpoint_text":"- Complete Response Rate (CRR): Percentage of participants who achieved ≥ complete response (CR), according to IMWG Uniform Response Criteria","definition_or_measurement_approach":"Percentage of participants achieving ≥ complete response per IMWG Uniform Response Criteria."}
• {"endpoint_text":"- Very Good Partial Response Rate (VGPRR) : Percentage of participants who achieved ≥ VGPR, according to IMWG Response Criteria","definition_or_measurement_approach":"Percentage of participants achieving ≥ very good partial response per IMWG Response Criteria."}
• {"endpoint_text":"- Progression-Free Survival (PFS) : Time from enrollment to the first documentation of progressive disease (PD) or death from any cause during study, whichever occurs earlier","definition_or_measurement_approach":"Time from enrollment to first documentation of progressive disease (PD) or death from any cause."}
• {"endpoint_text":"- Time-to-Response (TTR) : Time from first dose to the first documentation of response (≥ PR)","definition_or_measurement_approach":"Time from first dose to first documentation of response (≥ PR)."}
• {"endpoint_text":"- Duration of Response (DOR) : Time from the first documentation of response (≥ PR) to the first documentation of PD or death","definition_or_measurement_approach":"Time from first documentation of response (≥ PR) to first documentation of progressive disease (PD) or death."}

Spain

Latest Decision Or Authorization Date

29-01-2026

Number Of Sites

3

Number Of Participants

26

Norway

Latest Decision Or Authorization Date

29-01-2026

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Celgene Corp.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Development LP

Responsibilities

Serology/ endocrinology, medical image analysis/ review - X-ray, MRI, ultrasound, etc.

Name

Syneos Health Inc.

Name

Icon Clinical Research LLC

Responsibilities

Medical image analysis/ review - X-ray, MRI, ultrasound, etc.

Name

QPS LLC

Responsibilities

TS and BioA

Third parties

• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Bone Marrow Biopsy for Histology, Serum for SARS-CoV-2 serology, PK CC-92480 plasmaPK Tazemetostat plasma, PK BMS-986158 plasma, PK Trametinib plasma, PK M3/M4 of CC-92480 plasma","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Serology/ endocrinology, medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"PK testing and reporting","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"Serology/ endocrinology, Bone Marrow Biopsy processing, Bone Marrow Aspirate processing and analysis, %plasma cells, CD138+/- cells and PBMC isolation, flow cytometry, short term sample storage","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"TS and BioA","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Sample management, kit building, storage and distribution of samples to other vendors for analysis.","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Hematogenix Laboratory Services Limited","duties_or_roles":"Flow cytometry-based analysis of BM for MRD","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample storage for Bone Marrow Aspirate for cytogenetics, Bone Marrow Aspirate for MRD analysis, Whole Blood for Immunophenotyping, PBMC for immune cell activity and plasma for cytokines, Whole Blood for Pharmacogenomics","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements, electronic study-related comunications to patients","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}