Clinical trial NCT06163898: A Study to Evaluate Alnuctamab in Combination With Mezigdomide in Participants With Relapsed and/or Refractory Multiple Myeloma
Official title: A Phase 1b/2a, Multicenter, Open-label Study 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2023-12-11
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
Secondary outcomes:
measure: Complete Response Rate (CRR)
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)
measure: Very Good Partial Response Rate (VGPRR)
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)
measure: Progression-free Survival (PFS)
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)
measure: Time-to-Response (TTR)
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)
measure: Duration of Response (DOR)
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)
measure: Overall Survival (OS)
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)
measure: 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)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0033
state: Alabama
city: New Haven
country: United States
facility: Local Institution - 0035
state: Connecticut
city: New York
country: United States
facility: Local Institution - 0018
state: New York
city: Petah-Tikva
country: Israel
facility: Local Institution - 0021
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Local Institution - 0030
state: HaMerkaz
city: Jerusalem
country: Israel
facility: Local Institution - 0020
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: