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MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma

NCT05090566

TerminatedPhase 2

Sponsor: Pfizer

Conditions: Multiple Myeloma

Interventions: Elranatamab + Nirogacestat, Elranatamab + lenalidomide + dexamethasone

Countries: United States, Canada

The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy
* Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody
* Measurable disease defined by at least one of the following:

  1. Serum M-protein \>/= 0.5 g/dL by SPEP
  2. Urinary M-protein excretion \>/= 200 mg/24 hours by UPEP
  3. Serum immunoglobulin FLC \>/= 10 mg/dL (\>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
* ECOG performance status 0 -1
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade \</= 1

Exclusion Criteria:

* Active plasma cell leukemia
* Amyloidosis
* Stem cell transplant with 12 weeks prior to enrollment, or active GVHD
* POEMS syndrome
* Any active uncontrolled bacterial, fungal, or viral infection
* Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment
* Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer)
* Sub-Study A Only: Previous treatment with BCMA bispecific antibody
* Sub-Study B Only: Previous treatment with BCMA directed therapy

Locations (25)

Gilbert, Arizona, United States
Gilbert, Arizona, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Beverly Hills, California, United States
Encino, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Tarzana, California, United States
Coral Gables, Florida, United States
Coral Gables, Florida, United States
Deerfield Beach, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Calgary, Alberta, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada