Trial NCT06152575
MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
- Phase
- Phase 3
- Sponsor
- Pfizer
- Conditions
- Multiple Myeloma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
* Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
* Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
* Have clinical laboratory values within the specified range.
* ECOG (Eastern Cooperative Oncology Group) performance status ≤2.Performance status
* Not pregnant or breastfeeding and willing to use contraception.Pregnancy
Exclusion Criteria:
* Smoldering multiple myeloma.
* Plasma cell leukemia.
* Amyloidosis.
* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
* Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.Brain metastases
* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
* Any active, uncontrolled bacterial, fungal, or viral infection.
* Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)Prior malignancy
* Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
* Unable to receive investigator's choice therapy.
* Live attenuated vaccine within 4 weeks of the first dose of study intervention.
* Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.
Restrictions found (4)
- Brain metastasesOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG ≤2
Show in the text - PregnancyOutrightinclusionShow in the text
- Prior malignancyOutrightexclusion
within 3 years
Show in the text
Recruiting in Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Suffolk County
- BIDMC Research Pharmacy · Boston, Suffolk County