TerminatedPhase 1

A Study to Evaluate Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma

Stopped: Business objectives have changed

United States, Israel4 participantsStarted 2024-02-27

Plain-language summary

The purpose of this study is to determine the recommended dose and schedule, and evaluate the safety and preliminary efficacy of alnuctamab in combination with mezigdomide in participants with relapsed and/or refractory multiple myeloma.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Participant has a history of RRMM, and must: * Part A: Have previously received ≥ 3 prior lines of anti-myeloma therapy. * Part B and Part C: Have received 1 to 3 prior lines of anti-myeloma therapy. Exclusion Criteria: • Must not have previously received alnuctamab or mezigdomide. Note: Other protocol-defined inclusion/exclusion criteria apply

What they're measuring

Number of participants with adverse events (AEs)

Timeframe: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)

Number of participants with serious AEs (SAEs)

Timeframe: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)

Number of participants with AEs leading to discontinuation

Timeframe: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)

Number of deaths

Timeframe: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)

Number of participants with Dose-limiting toxicities (DLTs)

Timeframe: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)

Overall Response Rate (ORR)

Timeframe: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)

Trial details

NCT IDNCT06163898

SponsorCelgene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-03

View on ClinicalTrials.gov More Multiple Myeloma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of participants with adverse events (AEs)

Timeframe: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)

Number of participants with serious AEs (SAEs)

Timeframe: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)

Number of participants with AEs leading to discontinuation

Timeframe: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)

Number of deaths

Timeframe: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)

Number of participants with Dose-limiting toxicities (DLTs)

Timeframe: Up until 28 days after the last participant discontinues mezigdomide or 80 days after the last participant discontinues alnuctamab, whichever is longer (up to approximately 5 years)

Overall Response Rate (ORR)

Timeframe: From first participant enrollment until the last participant is no longer evaluable for response, or has progressed or the last survival follow-up (Up to approximately 5 years)