| Title |
A phase 1B, open-label study of Elranatamab in combination with Iberdomide in participants with relapsed refractory multiple myeloma |
| Protocole ID |
MagnetisMM-30 (C1071030) |
| ClinicalTrials.gov ID |
NCT06215118 |
| Cancer Type(s) |
Myeloma |
| Phase |
Phase I |
| Stage |
Relapse/refractory (2nd line and more) |
| Study Type |
Clinical |
| Drug |
Elranatamab et Iberdomide |
| Institution |
CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
 HOPITAL FLEURIMONT
3001 12e Avenue Nord, Sherbrooke, QC, J1H 5N4
|
| City |
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| Principal Investigator |
Dr. Michel Pavic
|
| Coordinator |
Christine Lawson
819-346-1110 poste 12942
|
| Status |
Recruiting |
| Activation Date |
11-07-2024 |
| Eligibility Criteria |
- Prior diagnosis of multiple myeloma as defined by IMWG criteria
- Measurable disease based on IMWG criteria as defined by at least 1 of the following:
- Serum M-protein ≥0.5 g/dL by SPEP
- Urinary M-protein excretion ≥200 mg/24 hour by UPEP
- Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (<0.26 or >1.65)
- Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
- Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
- ECOG performance status 0-1
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
|
| Exclusion Criteria |
- Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome
- Impaired cardiovascular function or clinically significant cardiovascular diseases
- Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
- Participants with any active, uncontrolled bacterial, fungal, or viral infection
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Previous treatment with:
- BCMA-directed or CD3 redirecting therapy
- Iberdomide (CC-220) or Mezigdomide
- Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study
- Administration with an investigational product within 30 days preceding the first dose of study intervention
- Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis
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Groupe d'étude en oncologie du Québec