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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06163898
• Other study ID #: CA058-002
• Secondary ID: 2023-504367-16-0
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: February 27, 2024
• Est. completion date: February 13, 2032

Study information

• Verified date: June 2024
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: February 13, 2032
• Est. primary completion date: February 13, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Alnuctamab
Specified dose on specified days
• Mezigdomide
Specified dose on specified days
• Dexamethasone
Specified dose on specified days

Locations

Country	Name	City	State
Israel	Local Institution - 0020	Jerusalem
Israel	Local Institution - 0021	Petah-Tikva	HaMerkaz
Israel	Local Institution - 0030	Ramat Gan	HaMerkaz
United States	Local Institution - 0033	Birmingham	Alabama
United States	Local Institution - 0035	New Haven	Connecticut
United States	Local Institution - 0018	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)		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)
Primary	Number of participants with serious AEs (SAEs)		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)
Primary	Number of participants with AEs leading to discontinuation		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)
Primary	Number of deaths		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)
Primary	Number of participants with Dose-limiting toxicities (DLTs)		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)
Primary	Overall Response Rate (ORR)	Phase 2 only	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	Complete Response Rate (CRR)		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	Very Good Partial Response Rate (VGPRR)		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	Progression-free Survival (PFS)		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	Time-to-Response (TTR)		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	Duration of Response (DOR)		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	Overall Survival (OS)		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	ORR	Phase 1 only	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)

External Links

•   BMS Clinical Trial Information