Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma

Sponsor
University Hospital, Caen
Study ID
NCT03757221
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ixazomib and Daratumumab — COMBINATION_PRODUCT
    Daratumumab will be administrated every week for the first 2 cycles. For cycle 3 to 6, it will be administrated every two weeks at day 1 and day 15. From cycle 7 until progression Daratumumab will be administrated every 4 weeks. Ixazomib will be administrated every week three weeks on one week off at D1, D8 and D15 on a 28-d cycle basis. Dexamethasone will not be given except one series of 4 days of dexamethasone, 20 mg/day or a maximum of 80 mg, for emergencies and complications at initiation of treatment.

Study Details

Multiple myeloma is an incurable hematological malignancy that affects older patients. Currently, despite recent progress, the disease relapses more or less quickly after initial treatment and requires the resumption of treatment with new drugs associated with cortisone, whose side effects are important. The investigators propose to conduct a phase 2 testing the combination ixazomib - daratumumab without dexamethasone.

Key Dates

Start date
Feb 7, 2019
Status verified
May 2026
Primary completion
Sep 15, 2022
Completion
Apr 28, 2024

Study Design

Enrollment
55 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination ixazomib + daratumumab without dexamethasone
    Elderly Relapse Refractory Multiple Myeloma Patients treated by Combination ixazomib + daratumumab without dexamethasone

Primary Outcome Measure

Very Good Partial Response (VGPR) + Complete Response (CR) Rate using the IMWG response criteria [ Time Frame: 12 months ]

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