ALNUCTAMAB for Relapsed and/or Refractory Multiple Myeloma

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 with history of RRMM treated with ≥ 3 prior lines of antimyeloma therapy (Part A) or 1 to 3 prior lines of anti-myeloma therapy (Parts B and C).\n- Measurable MM by central laboratory.\n- Eastern Cooperative Oncology Group performance status of 0 to 1.\n- Adherence to contraception requirements."}

Exclusion criteria

• {"criterion_text":"- Prior treatment with mezigdomide or alnuctamab.\n- Other exclusion criteria can be found in the protocol."}

Primary endpoints

• {"endpoint_text":"- All phases: Type, frequency, seriousness, and severity of all aAEs;. To be assessed continuously for all participants until 80 days after the last dose of alnuctamab or 28 days after the last dose of mezigdomide, whichever is later.","definition_or_measurement_approach":"Assessed continuously for all participants until 80 days after the last dose of alnuctamab or 28 days after the last dose of mezigdomide, whichever is later."}
• {"endpoint_text":"- Phase 1b: Establish RP2D and dosing schedule of mezigdomide in combination with alnuctamab for Phase 2a expansion. To be assessed at end of Phase 1.","definition_or_measurement_approach":"To be assessed at end of Phase 1 (determination of recommended Phase 2 dose and schedule)."}
• {"endpoint_text":"- Phase 2a: Overall response rate. To be assessed every cycle for all participants starting at Cycle 2 Day 1 until end of treatment. Participants in efficacy follow-up may be assessed every 8 weeks until dprogression, withdrawal of consent, death, or initiation of new systemic anticancer therapies.","definition_or_measurement_approach":"Overall response rate assessed every cycle starting at Cycle 2 Day 1 until end of treatment; efficacy follow-up assessments may occur every 8 weeks until progression, withdrawal, death, or new systemic anticancer therapy."}

Secondary endpoints

• {"endpoint_text":"- All phases: Other myeloma response measures such as very good partial or better rate and complete response rate; time-to-response (the time it takes for a myeloma response after treatment) and duration of response. These will be assessed for all participants starting at Cycle 2 Day 1. Other measures include progression-free survival (the amount of time after starting treatment that the cancer does not worsen) and overall survival, both of which will be assessed continuously","definition_or_measurement_approach":"Assessed for all participants starting at Cycle 2 Day 1; includes time-to-response, duration of response, progression-free survival and overall survival assessed continuously."}
• {"endpoint_text":"- Phase 1b: overall response rate. To be assessed every cycle for all participants starting at Cycle 2 Day 1 until end of treatment. Participants in efficacy follow-up may be assessed every 8 weeks until dprogression, withdrawal of consent, death, or initiation of new systemic anticancer therapies.","definition_or_measurement_approach":"Overall response rate assessed every cycle starting at Cycle 2 Day 1 until end of treatment; efficacy follow-up assessments may occur every 8 weeks until progression, withdrawal, death, or new systemic anticancer therapy."}

Denmark

Earliest CTIS Part Ii Submission Date

09-12-2023

Latest Decision Or Authorization Date

11-01-2024

Processing Time Days

33

Number Of Sites

2

Number Of Participants

14

France

Latest Decision Or Authorization Date

15-12-2023

Germany

Latest Decision Or Authorization Date

18-12-2023

Spain

Latest Decision Or Authorization Date

18-12-2023

Netherlands

Latest Decision Or Authorization Date

18-12-2023

Primary sponsor

Full Name

Celgene International II S.a.r.l.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Pharmaceutical Product Development LLC

Responsibilities

Serology/ endocrinology, medical image analysis/ review - X-ray, MRI, ultrasound, etc.

Name

QPS LLC

Responsibilities

Mezigdomide PK

Third parties

• {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"IVRS – treatment randomization, Core Technology Services","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Serology/ endocrinology, medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance: Medical review & Cases Data Entry.","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"Genomic Analysis","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"QPS LLC","duties_or_roles":"Mezigdomide PK","organisation_type":"Pharmaceutical company"}