← Back to results
NCT06050512PHASE1, PHASE2WITHDRAWN

Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma

Phase I/II Trial of Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma

Sponsor: Kathleen Dorritie + Bristol-Myers Squibb

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Request endpoint coverage

Key Facts

Study type
INTERVENTIONAL
Conditions
Relapsed and Refractory Multiple Myeloma
Interventions
Mezigdomide, Ixazomib, Dexamethasone
Enrollment
Primary completion
Oct 2026
Study completion
Oct 2026
First posted
Sep 2023
Last updated
Nov 2024

Primary Endpoints (CT.gov)

Phase l: Recommended Phase II Dose (RP2D)

Time frame: Up to 17 months

Phase ll: Overall Response Rate (ORR)

Time frame: Up to 36 months

Secondary Endpoints

Incidence and severity of Adverse Events

Depth of Response

Duration of Response (DOR)

Eligibility Criteria

Inclusion Criteria: * ECOG performance status \< 2 * Patients must have a confirmed diagnosis of multiple myeloma and have received 1-3 prior lines of therapy and must be: * Exposed to a proteasome inhibitor, IMiD, and anti-CD38 antibody prior to enrollment. Patients must have measurable evidence of multiple myeloma defined as one of the following: * Serum M protein ≥ 0.5 g/dL * Abnormal free light chain ratio, provided involved light chain is \>10mg/dL * Urine M protein ≥ 200 mg/24 hours * Hematologic laboratory parameters of: * Absolute neutrophil count (ANC) \> 1,000/mm3 * Hemoglobin \> 8g/dL * Platelet count \> 75,000/μL if plasma cells account for \< 50% bone marrow * Nucleated cells and \> 50,000/μL if plasma cells account for \> 50% of bone marrow nucleated cells * Non-hematologic laboratory parameters of: * Total Bilirubin of \< 2 times the upper limit of normal * ALT and AST \< 3 times the upper limit of normal * Corrected serum calcium \>13 mg/dL * Est

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Request coverage →

Source

Open on ClinicalTrials.gov