Phase 3Recruiting
Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma
A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration Versus Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma
- Sponsor
- Canadian Cancer Trials Group (Research network)
- Enrolment
- 570 planned
- Conditions
- Multiple Myeloma
- Interventions
- Daratumumab; Lenalidomide; Dexamethasone; Isatuximab
- Ages
- adults, older adults
- Registry
- NCT06182774
Full record on ClinicalTrials.gov
From the registry
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?
Primary outcomes
- Progression-Free Survival
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered