Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant (ASCENT)
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|ClinicalTrials.gov Identifier: NCT03289299|
Recruitment Status : Not yet recruiting
First Posted : September 20, 2017
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoldering Multiple Myeloma||Drug: Carfilzomib Drug: Lenalidomide Drug: Daratumumab Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||83 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects will receive treatment in 3 phases - induction (6 cycles), consolidation (6 cycles), and maintenance (12 cycles).|
|Masking:||None (Open Label)|
|Official Title:||Aggressive Smoldering Curative Approach Evaluating Novel Therapies (ASCENT): A Phase 2 Trial of Induction, Consolidation, and Maintenance in Subjects With High Risk Smoldering Multiple Myeloma (SMM)|
|Anticipated Study Start Date :||March 30, 2018|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||March 1, 2026|
Experimental: Arm A
Non-high dose treatment in 3 phases Induction 6 cycles: carfilzomib, lenalidomide, daratumumab, dexamethasone Consolidation 6 cycles: carfilzomib, lenalidomide, daratumumab, dexamethasone Maintenance 12 cycles: lenalidomide, daratumumab
36 mg/m2 IV given on days 1, 2, 8, 9, 15, and 16 of each cycle during induction and consolidation phases of the study.Drug: Lenalidomide
25 mg po given on days 1-21 of each cycle during the induction and consolidation phases.
10 mg po given on days 1-21 of each cycle during the maintenance phase.
16 mg/kg IV given on days 1, 8, 15, and 22 of cycles 1-2; days 1 and 15 of cycles 3-6; day 1 of cycle 7-12; Day 1 of odd cycles for cycles 13-24.Drug: Dexamethasone
40 mg oral given on days 1, 8, 15, and 22 of cycles 1-6 20 mg oral given on days 1, 8, 15, and 22 of cycles 7-12
- Stringent complete response rate [ Time Frame: During treatment ]A confirmed sCR on 2 consecutive evaluations at any time during the course of treatment.
- MRD negativity after each treatment phase [ Time Frame: 6 months, 12 months, and 2 years ]MRD negativity after induction, consolidation, and maintenance
- MRD negativity at 1 year post treatment [ Time Frame: 1 year post treatment ]Persistent MRD negativity rate will be evaluated at 1 year after completion of planned treatment consisting of induction, consolidation, and maintenance.
- Overall Survival [ Time Frame: up to 10 years post registration ]time of registration to death due to any cause
- Progression-free survival [ Time Frame: up to 10 years post registration ]the time from registration to the earliest date of documentation of disease progression or death due to any cause
- Adverse events [ Time Frame: 2 years ]all eligible subjects that have initiated treatment will be considered evaluable for assessing adverse even rates. The maximum grade for each type of adverse event will be recorded. Relationship to trial treatment will be taken into consideration.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289299
|Contact: Erica L Kim, MPHemail@example.com|
|Contact: Robert Wittig, MBAfirstname.lastname@example.org|
|Principal Investigator:||Shaji Kumar, MD||Mayo Clinic|
|Principal Investigator:||Brian Durie, MD||International Myeloma Foundation|