Phase 1b/2a Study to Evaluate Mezigdomide in Combination with Elranatamab in Relapsed and/or Refractory Multiple Myeloma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Celgene Corp.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

22 Jan 2026 → ongoing

Decision date (initial)

2025-10-23

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2025-522090-11-00

WHO UTN

U1111-1317-4901

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Pharmacokinetic, Dose response, Safety

The main goal is to determine the safety and tolerability of Mezigdomide in combination with Elranatamab in participants with RRMM and to determine the recommended Phase 2 dose (RP2D; the dose to be used in subsequent, larger studies) and schedule of Mezigdomide when given in combination in participants with RRMM.

Secondary objectives 1

1. The secondary goal is to see how well mezigdomide works in combination with elranatamab and to see if there is any small amount of detectable disease (minimum residual disease; MRD) after study treatment among participants who achieve a complete response or better (CR; a type of overall response for myeloma after treatment).

Conditions and MedDRA coding

Relapsed or Refractory Multiple Myeloma (RRMM)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. additional Infromation regarding Bristol-Myers Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Signed Written Informed Consent
2. Participant with a history of RRMM who received 2 to 4 prior lines of anti-myeloma therapy.
3. Participants must have measurable disease as determined by local laboratory.
4. Participant consents to hospitalization requirements.
5. Participant consents to serial BMAs and/or BMBs during screening, study treatment, and at EOT.
6. Participant has an ECOG PS of 0 to 1

Exclusion criteria 8

1. Participant with known current or history of CNS involvement of MM
2. Participant cannot tolerate oral medications and/or has gastrointestinal disease (within 3 months of screening) or any gastrointestinal surgery that may significantly alter the absorption of oral study treatment
3. Ongoing Grade ≥ 2 peripheral sensory or motor neuropathy.
4. History of GBS or GBS variants, or history of any Grade ≥ 3 peripheral motor polyneuropathy.
5. HIV positive patients.
6. Participant has known chronic, active HBV/HCV infection
7. Participant has a prior history of malignancies other than MM, except if the participant has been free of the disease for ≥ 3 years.
8. Participant has a history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or CNS bleed, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, or psychosis

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The main endpoints include the type, frequency, seriousness, and severity of all aAEs.
2. Establish the RP2D and dosing schedule of mezigdomide in combination with elranatamab.

Secondary endpoints 3

1. The secondary endpoints relate to the effectiveness of the treatment. Specific metrics to be examined include the percentage of participants who respond to treatment (overall response rate; ORR), the percentage of participants who have a very good partial response or better
2. The percentage of participants who have a very good partial response or better (VGPRR) or complete response or better (CRR) as well as additional measures of response including the time to response (TTR; how long it takes for the treatment to start working), duration of response (DOR; how long the response lasts), progression free survival (PFS; how long it takes for the disease to get worse), and overall survival (OS; how long participants stay alive after receiving the treatment
3. Number of participants who do not have detectable disease in the body with a sensitive laboratory test. This is called minimum residual disease negativity rate.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 8

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Celgene Corp.

Sponsor organisation

Celgene Corp.

Address

Route 206 And Province Line Road

City

Princeton

Postcode

08543-4000

Country

United States

Scientific contact point

Organisation

Celgene Corp.

Contact name

GSM-CT

Public contact point

Organisation

Celgene Corp.

Contact name

GSM-CT

Third parties 6

Locations

4 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 29 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications