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Phase 1b/2a Study to Evaluate Mezigdomide in Combination with Elranatamab in Relapsed and/or Refractory Multiple Myeloma
EU CTIS ID: 2025-522090-11-00
What this study is testing
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.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed Written Informed Consent
- Participant with a history of RRMM who received 2 to 4 prior lines of anti-myeloma therapy.
- Participants must have measurable disease as determined by local laboratory.
- Participant consents to hospitalization requirements.
- Participant consents to serial BMAs and/or BMBs during screening, study treatment, and at EOT.
- Participant has an ECOG PS of 0 to 1
You likely can't join if
- Participant with known current or history of CNS involvement of MM
- 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
- Ongoing Grade ≥ 2 peripheral sensory or motor neuropathy.
- History of GBS or GBS variants, or history of any Grade ≥ 3 peripheral motor polyneuropathy.
- HIV positive patients.
- Participant has known chronic, active HBV/HCV infection
See the full eligibility criteria
- Signed Written Informed Consent
- Participant with a history of RRMM who received 2 to 4 prior lines of anti-myeloma therapy.
- Participants must have measurable disease as determined by local laboratory.
- Participant consents to hospitalization requirements.
- Participant consents to serial BMAs and/or BMBs during screening, study treatment, and at EOT.
- Participant has an ECOG PS of 0 to 1
- Participant with known current or history of CNS involvement of MM
- 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
- Ongoing Grade ≥ 2 peripheral sensory or motor neuropathy.
- History of GBS or GBS variants, or history of any Grade ≥ 3 peripheral motor polyneuropathy.
- HIV positive patients.
- Participant has known chronic, active HBV/HCV infection
- Participant has a prior history of malignancies other than MM, except if the participant has been free of the disease for ≥ 3 years.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- China
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; China; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.