Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma

Sponsor
Canadian Cancer Trials Group
Study ID
NCT06182774
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Dose determined at enrollment
  • Lenalidomide — DRUG
    Dose determined at enrollment
  • Dexamethasone — DRUG
    Dose determined at enrollment
  • Isatuximab — DRUG
    Dose determined at enrollment

Study Details

Currently, daratumumab or isatuximab are given continuously (non-stop), along side lenalidomide, and dexamethasone as part of multiple myeloma treatment. are given continuously (non-stop). Recent observations suggest that stopping daratumumab or isatuximb after about a year and a half of treatment may work just as well as giving them continuously with lenalidomide and dexamethasone. Sometimes, bortezomib is also given. This study is being done to answer the question: is less daratumumab or isatuximab treatment as good as more?

Key Dates

Start date
Apr 10, 2024
Status verified
Jan 2026
Primary completion
Jan 31, 2032
Completion
Jul 31, 2032

Study Design

Enrollment
570 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lenalidomide & Dexamethasone
  • Active Comparator: Daratumumab, Lenalidomide, Dexamethasone & Isatuximab
    Standard of Care

Primary Outcome Measure

Progression-Free Survival [ Time Frame: 9.1 years ]

Central Contacts

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