Phase 3 Study to Evaluate Mezigdomide (CC-92480/BMS-986348) in Combination with Carfilzomib and Dexamethasone in Relapsed or Refractory Multiple Myeloma: SUCCESSOR-2

JRCT ID: jRCT2071230095

Registered date:25/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Multiple Myeloma
• Date of first enrollment: 06/02/2024
• Target sample size: 41
• Countries of recruitment: USA,Japan,Argentina,Japan,UK,Japan,Israel,Japan,Italy,Japan,India,Japan,Australia,Japan,Austria,Japan,Netherlands,Japan,Canada,Japan,Korea,Japan,Greece,Japan,Colombia,Japan,Spain,Japan,Singapore,Japan,Taiwan,Japan,China,Japan,Denmark,Japan,Germany,Japan,Norway,Japan,Hungary,Japan,Hong Kong,Japan,Brazil,Japan
• Study type: Interventional

Intervention(s)

Arm A: Mezigdomide, Carfilzomib and Dexamethasone
Arm B: Carfilzomib and Dexamethasone

Outcome(s)

• Primary Outcome: progression-free survival
• Secondary Outcome: Overall Survival, Overall Response, Very good partial response, Complete response, Time to Response, Duration of Response, Time to Progression, Time to Next Treatment, Progression-free Survival 2, adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Participant has documented diagnosis of Multiple Myeloma and measurable disease.
Participant has received at least 1 prior line of anti-myeloma therapy.
Participant must have received prior treatment with lenalidomide and at least 2 cycles of
an anti-CD38 monoclonal antibody.

Exclude criteria

Participant who has had prior treatment with mezigdomide or carfilzomib.
Participant has previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of initiating
study intervention.

Related Information

• Primary Sponsor: Engelhardt Brian
• Secondary ID(s): NCT05552976