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)

Study Purpose

The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who:

- Are 18 years of age or older and have MM.

- Have received treatments before for MM.

- Have MM that has returned or not responded to their most recent treatment.

Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:

- a shot under the skin at the study clinic.

- through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.

Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

- Not pregnant or breastfeeding and willing to use contraception.

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.

- 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) - 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06152575
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Pfizer
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pfizer CT.gov Call Center
Principal Investigator Affiliation	Pfizer
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, Japan, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Elranatamab

Participants will receive elranatamab monotherapy

Active Comparator: Investigator's Choice

Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)

Interventions

Drug: - Elranatamab

Elranatamab will be administered subcutaneously

Drug: - Elotuzumab

Elotuzumab will be administered intravenously

Drug: - Pomalidomide

Pomalidomide will be administered orally

Drug: - Dexamethasone

Dexamethasone will be administered orally

Drug: - Bortezomib

Bortezomib will be administered subcutaneously or intravenously

Drug: - Carfilzomib

Carfilzomib will be administered intravenously

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Beverly Hills Cancer Center, Beverly Hills, California

Status

Recruiting

Address

Beverly Hills Cancer Center

Beverly Hills, California, 90211

Site Contact

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