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Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma

Phase I/II Study of Mezigdomide and Elranatamab for Relapsed/Refractory Multiple Myeloma Patients

NCT06645678•YOUNGIL KOH

Summary

The goal of this clinical trial is to find out how well a combination of two medicines (mezigdomide and elranatamab) works in treating patients with refractory/relapsed multiple myeloma.

Detailed Description

This is a phase I/II (2 parts), open-label, single arm, multicenter study to evaluate the efficacy and safety of elranatamab in combination with mezigdomide. Part 1 (safety cohort): Since the combination of elranatamab with mezigdomide has not previously been evaluated, Part 1 (safety cohort) of the study will be conducted in up to approximately 12 participants to select the optimal RP2D and to assess the safety, tolerability, and preliminary efficacy. Part 2 (expansion cohort): In Part 2 (expansion cohort), approximately 63 participants will be enrolled. The primary objective of Part 2 is to determine the overall response rate per IMWG criteria at 24 months after enrollment. Participants will receive elranatamab, mezigdomide and dexamethasone.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must satisfy the following criteria to be enrolled in the study:
•* Subject is ≥ 19 years of age at the time of signing the informed consent form (ICF).
•② Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
•* Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
•④ Subject has documented diagnosis of MM and measurable disease, defined as any of the following: A. M-protein ≥ 0.5 g/dL by serum protein electrophoresis (sPEP) or B. M-protein ≥ 200 mg/24-hour urine collection by urine protein electrophoresis (uPEP) or C. For subjects without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \> 100 mg/L (10 mg/dL) involved light chain and an abnormal kappa/lambda FLC ratio.
•C. Known to be seropositive for hepatitis C virus (HCV); anti-HCV antibody positive and HCV- ribonucleic acid (RNA) quantitation positive.
•22 Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, pomalidomide (including ≥ Grade 3 rash during prior IMiD therapy), or dexamethasone or the excipients contained in the formulations, or subject has any contraindications per local PI.
•23 Ongoing Grade 3 or higher peripheral sensory or motor neuropathy, history of Guillan-Barre syndrome (GBS) or GBS variants, or history of any Grade \> 3 peripheral motor polyneuropathy.
•24 Subject is an individual who is pregnant, nursing or breastfeeding, or who intends to become pregnant during participation in the study.

Exclusion Criteria

•⑤ Subject has received 2 or more prior lines of antimyeloma therapy. (Note: One line can contain several phases \[e.g., induction, (with or without) hematopoietic stem cell transplant, (with or without) consolidation, and/or (with or without) maintenance therapy).
•⑥ Subject must have received at least one proteasome inhibitor and lenalidomide.
•⑦ Subject achieved minimal response or better to at least 1 prior antimyeloma therapy.
•* Subject must have documented disease progression during or after their last antimyeloma regimen.
•⑨ Subject has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
•⑩ Individual of childbearing potential (IOCBP) must: A. Have two negative pregnancy tests as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. This applies even if the subject practices true abstinence\* from heterosexual contact.
•B. Either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with, 2 forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting study treatment, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of mezigdomide or 150 days after the last dose of elranatamab, whichever is longer.
•Note: A IOCBP (Individual of childbearing potential): an individual who: 1) has achieved menarche (first menstrual cycle) at some point; 2) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral salpingectomy (the surgical removal of the fallopian tubes) or oophorectomy (the surgical removal of both ovaries) or 3) has not been naturally postmenopausal (without an alternative medical cause eg, amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (ie, has had menses at any time during the preceding 12 consecutive months).
•⑪ Male subjects must: A. Practice true abstinence\* (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant individual or an individual of childbearing potential while participating in the study, during dose interruptions and for at least 28 days after the last dose of mezigdomide whichever is longer, even if he has undergone a successful vasectomy.
•True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. \[Periodic abstinence (e.g., calendar, ovulation, post-ovulation methods) and withdrawal are not acceptable methods of contraception\].
+30 more criteria

Locations (7)

National University Hospital (NUH)

Singapore, Singapore

Singhealth Duke NUS blood cancer center

Singapore, Singapore

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Asan Medical Center, University of Ulsan College of Medicine

Seoul, South Korea

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Seoul, South Korea

Key Dates

Start Date

November 26, 2024

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2027

Last Updated

December 3, 2025

Enrollment

ESTIMATED participants

Conditions

Relapsed Refractory Multiple Myeloma (RRMM)

Interventions

Elranatamab

DRUG

Mezigdomide

DRUG

Dexamethasone

DRUG

Contacts

Youngil Koh, MD, PhD

CONTACT

82-02-2072-7217 go01@snu.ac.kr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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