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A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06215118
Protocol IDs
C1071030 (primary)
NCI-2024-03007
MagnetisMM-30
Study Sponsor
Pfizer Inc

Summary

The main purpose of the study is to understand how safe and tolerable is elranatamab when
given along with iberdomide.

There are 2 parts to this study. Part 1 will look at how safe and tolerable is
elranatamab when given with iberdomide. Part 2 will look at the correct amount of this
combination that can be given to patients with relapsed or refractory multiple myeloma.

Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce
antibodies). Refractory means a disease or condition that does not respond to treatment.
Relapsed means the return of a disease after a period of improvement.

All study medicines are given in cycles that last 28 days. Everyone taking part in this
study will receive elranatamab as a shot under the skin. Iberdomide will be taken by
mouth once a day for 21 days over a 28-day cycle.

Participants will receive study medicine until:

- their disease progresses or,

- they experience unacceptable side effects or,

- they choose to no longer take part in the study.

The study will look at the experiences of people receiving the study medicines. This will
help see if the study medicines are safe and can be used for multiple myeloma treatment.

Eligibility

  1. Prior diagnosis of multiple myeloma as defined by IMWG criteria
  2. Measurable disease based on IMWG criteria as defined by at least 1 of the following:
  3. Serum M-protein =0.5 g/dL by SPEP
  4. Urinary M-protein excretion =200 mg/24 hour by UPEP
  5. Serum immunoglobulin FLC =10 mg/dL (=100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (<0.26 or >1.65)
  6. Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
  7. Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
  8. ECOG performance status 0-1
  9. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.