ELRANATAMAB for Relapsed/refractory multiple myeloma

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Participant with known current or history of CNS involvement of MM\n- 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\n- Ongoing Grade ≥ 2 peripheral sensory or motor neuropathy.\n- History of GBS or GBS variants, or history of any Grade ≥ 3 peripheral motor polyneuropathy.\n- HIV positive patients.\n- Participant has known chronic, active HBV/HCV infection\n- Participant has a prior history of malignancies other than MM, except if the participant has been free of the disease for ≥ 3 years.\n- 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"}

Primary endpoints

• {"endpoint_text":"- The main endpoints include the type, frequency, seriousness, and severity of all aAEs.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Establish the RP2D and dosing schedule of mezigdomide in combination with elranatamab.","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":""}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":""}

Germany

Earliest CTIS Part Ii Submission Date

25-09-2025

Latest Decision Or Authorization Date

19-02-2026

Processing Time Days

147

Number Of Sites

3

Number Of Participants

7

Greece

Earliest CTIS Part Ii Submission Date

07-08-2025

Latest Decision Or Authorization Date

24-02-2026

Processing Time Days

201

Number Of Sites

2

Number Of Participants

6

Spain

Earliest CTIS Part Ii Submission Date

16-09-2025

Latest Decision Or Authorization Date

20-02-2026

Processing Time Days

157

Number Of Sites

2

Number Of Participants

5

Norway

Earliest CTIS Part Ii Submission Date

24-09-2025

Latest Decision Or Authorization Date

18-02-2026

Processing Time Days

147

Number Of Sites

2

Number Of Participants

6

Primary sponsor

Full Name

Celgene Corp.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Medidata Solutions Inc.

Responsibilities

Data Management Platform

Name

Iqvia Inc.

Responsibilities

Site payments and other operational duties (sponsorDuties codes listed)

Name

QPS LLC

Responsibilities

Mezigdomide PK samples

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"sample storage","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"Clinical chemistry, clinical heamatology, clinical microbiology, histopatology","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"flow-cytometry-based analysis of BM for MRD","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Codes: 1,10,11,12,6,8,9; explicit role listed: site payments","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"Mezigdomide PK samples","organisation_type":"Pharmaceutical company"}