| TITRE |
(EN) A phase 1B, open-label study of Elranatamab in combination with Iberdomide in participants with relapsed refractory multiple myeloma |
| PROTOCOLE ID |
MagnetisMM-30 (C1071030) |
| CLINICAL TRIAL.gov ID |
NCT06215118 |
| TYPE(S) DE CANCER |
Myélome |
| PHASE |
Phase I |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CIUSSS DE L'ESTRIE – CENTRE HOSP. UNIV. DE SHERBROOKE
3001 12e Avenue Nord
(819) 346-1110
|
| VILLE |
Sherbrooke
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Michel Pavic
|
| COORDONATEUR(RICE) |
Christine Lawson
christine.lawson.ciussse-chus@ssss.gouv.qc.ca
819-346-1110 poste 12942
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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
|
