A Study to Learn About the Effects of Cemsidomide in Combination With Elranatamab in Relapsed/Refractory Multiple Myeloma Subjects

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-30

Study Completion Date

2029-06-30

Brief Summary

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The main purpose of the study is to understand the safety and tolerability of cemsidomide when given along with elranatamab in subjects with relapsed or refractory multiple myeloma.

The first part of the study will evaluate different dose levels of cemsidomide in combination with elranatamab in a limited number of subjects. Approximately 3 different dose levels of cemsidomide in combination with elranatamab may be explored. Once a dose level is determined safe, additional subjects may be enrolled through expansion of the dose level. This expansion will provide further exploration of the safety and evaluation of preliminary antimyeloma activity.

Cemsidomide will be taken orally each cycle for 14 days on/14 days off (1 cycle=28 days). Elranatamab will be administered by subcutaneous injection twice a month. Dexamethasone will be administered weekly until a confirmed response but no longer than 4 cycles.

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Detailed Description

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Conditions

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Multiple Myeloma (MM)

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-randomized cemsidomide (tablet) plus elranatamab (subcutaneous injection)

Group Type EXPERIMENTAL

Cemsidomide

Intervention Type DRUG

IKZF1/3 degrader

Elranatamab

Intervention Type BIOLOGICAL

• BCMA-CD3 bispecific antibody

Interventions

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Cemsidomide

IKZF1/3 degrader

Intervention Type DRUG

Elranatamab

• BCMA-CD3 bispecific antibody

Intervention Type BIOLOGICAL

Other Intervention Names

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o PF-06863135 o ELREXFIO

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of multiple myeloma as defined by IMWG criteria
* Measurable disease based on IMWG criteria
* Received 1-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug (i.e., IKZF 1/3 degrader)
* ECOG performance status 0-2

Exclusion Criteria

* Smoldering multiple myeloma, POEMS Syndrome, systemic light chain amyloidosis, MDS
* Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
* Participants with any active, uncontrolled bacterial, fungal, or viral infection
* Prior treatment with a BCMA-directed TCE or BCMA-directed CAR-T therapy
* Administration with an investigational product within 30 days preceding the first dose of study intervention
* Inability or difficulty swallowing tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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