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

Multiple Myeloma

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.

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Conditions de participation

  • Sexe:

    ALL
  • Âges admissibles:

    18 and up

Critères de participation

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

Lieu de l'étude

Arthur J.E. Child Comprehensive Cancer Centre
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta
Canada

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The Ottawa Hospital - General Campus
The Ottawa Hospital - General Campus
Ottawa, Ontario
Canada

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Princess Margaret Cancer Centre
Princess Margaret Cancer Centre
Toronto, Ontario
Canada

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Étude parrainée par
Pfizer
Participants recherchés
Plus d'informations
ID de l'étude: NCT05090566