Ixazomib -Daratumumab Without Dexamethasone (IDara) in Elderly Relapse Refractory Multiple Myeloma (IDARA)
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|ClinicalTrials.gov Identifier: NCT03757221|
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : July 8, 2019
|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|
|Actual Study Start Date :||February 7, 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757221
|Contact: Margaret MACROemail@example.com|
|CHU CAEN Dept of Hematology||Recruiting|
|Caen, France, 14033|
|Principal Investigator: Margaret MACRO, MD|