Study Association of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab in Newly Diagnosed Standard Risk Multiple Myeloma

Sponsor
University Hospital, Toulouse
Study ID
NCT03669445
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Ixazomib — DRUG
    21-day cycles induction and 28-day cycles consolidation
  • Lenalidomide — DRUG
    21-day cycles induction and 28-day cycles consolidation and 28-day cycles maintenance therapy
  • Dexamethasone — DRUG
    21-day cycles induction and 28-day cycles consolidation
  • Daratumumab — DRUG
    21-day cycles induction and 28-day cycles consolidation

Study Details

The main objective of this study is to evaluate the minimal residual disease-negativity rate after administration of the combination of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab as induction and consolidation therapy in an intensive program in newly diagnosed standard risk multiple myeloma patients. For the induction therapy, each patient received 6 cycles of Lenalidomide, Ixazomib, Dexamethasone and Daratumumab, then peripheral blood stem cell harvest, intensification with autologous stem cell transplantation, consolidation therapy and maintenance.

Key Dates

Start date
Dec 31, 2018
Status verified
Jul 2020
Primary completion
Mar 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: four drugs combination
    21-day cycles induction, then 28-day cycles consolidation and maintenance with Lenalidomide, Ixazomib, and Dexamethasone Plus Daratumumab

Primary Outcome Measure

minimal residual disease-negativity rate [ Time Frame: 22 months ]

Central Contacts

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