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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-27

Study Completion Date

2026-02-19

Brief Summary

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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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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sub-Study A

BCMA-CD3 bispecific antibody + gamma secretase inhibitor

Group Type EXPERIMENTAL

Elranatamab + Nirogacestat

Intervention Type DRUG

BCMA-CD3 bispecific antibody + gamma secretase inhibitor

Sub-Study B

BCMA-CD3 bispecific antibody + immunomodulatory drug

Group Type EXPERIMENTAL

Elranatamab + lenalidomide + dexamethasone

Intervention Type DRUG

BCMA-CD3 bispecific antibody + immunomodulatory

Interventions

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Elranatamab + Nirogacestat

BCMA-CD3 bispecific antibody + gamma secretase inhibitor

Intervention Type DRUG

Elranatamab + lenalidomide + dexamethasone

BCMA-CD3 bispecific antibody + immunomodulatory

Intervention Type DRUG

Other Intervention Names

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PF-06863135, Ogsiveo PF-06863135; Revlimid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Banner Gateway Medical Center

Gilbert, Arizona, United States

Site Status

Banner Gateway Medical Pavilion

Gilbert, Arizona, United States

Site Status

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status

Banner Health d.b.a. Banner MD Anderson Cancer Center

Phoenix, Arizona, United States

Site Status

Beverly Hills Cancer Center

Beverly Hills, California, United States

Site Status