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A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05675449
Protocol IDs
C1071020 (primary)
NCI-2023-01590
MAGNETISMM-20
Study Sponsor
Pfizer Inc
NCI Full Details
http://clinicaltrials.gov/show/NCT05675449

Summary

The main purpose of the study is to evaluate the safety and tolerability of the combination
of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept.

There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of
elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms.
The first will evaluate the safety and tolerability of elranatamab when given in combination
with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus
maplirpacept.

All study medicines are given over 4-week cycles. Everyone taking part in this study will
receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly
carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth
(as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination
with maplirpacept as an IV infusion (given directly into a vein)

The investigators will examine the experiences of people receiving the study medicines. This
will help determine if the study medicines are safe and can be used for multiple myeloma
treatment. Participants will take part in this study for about 2 years after the first dose.

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.
  4. Urinary M-protein excretion =200 mg/24 hours.
  5. Serum immunoglobulin FLC =10 mg/dL (=100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  6. Part 1: Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy).
  7. Part 2: Received at least 3 prior lines of therapy for multiple myeloma who are refractory to at least one IMiD, one PI and one anti-CD38 antibody.
  8. ECOG performance status 0-1.
  9. Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1.
  10. Not pregnant or breastfeeding and willing to use contraception.
  11. Prior therapy with carfilzomib is allowed as long as the participant had (all apply): responded to most recent therapy with carfilzomib; Carfilzomib was not discontinued due to toxicity; Did not relapse within 60 days from discontinuation of carfilzomib; Will have at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment.

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.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.