Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma (IDARA)
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|ClinicalTrials.gov Identifier: NCT03757221|
Recruitment Status : Not yet recruiting
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Combination Product: Ixazomib and Daratumumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||We plan a single-arm non-randomized open label phase II study with a Fleming one stage hypothesis testing for the primary endpoint of VGPR (Very Good Partial Response) + CR (Complete Response) Rate during the twelve months follow-up. The efficacy of Daratumumab plus Ixazomib will be evaluated in comparison to a minimally effective lower threshold level of VGPR + CR.|
|Masking:||None (Open Label)|
|Official Title:||A Multicentre Open-label Phase II Study of Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Combination ixazomib + daratumumab without dexamethasone
Elderly Relapse Refractory Multiple Myeloma Patients treated by Combination ixazomib + daratumumab without dexamethasone
Combination Product: Ixazomib and Daratumumab
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.
- Very Good Partial Response (VGPR) + Complete Response (CR) Rate using the IMWG response criteria [ Time Frame: 12 months ]The primary endpoint is the Very Good Partial Response (VGPR) + Complete Response (CR) Rate using the IMWG response criteria. Using IMWG criteria for best response reached at during the twelve months follow-up.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757221
|Contact: Margaret MACROemail@example.com|