Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant (ASCENT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03289299|
Recruitment Status : Active, not recruiting
First Posted : September 20, 2017
Last Update Posted : February 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Smoldering Multiple Myeloma||Drug: Carfilzomib Drug: Lenalidomide Drug: Daratumumab Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 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)|
|Actual Study Start Date :||May 25, 2018|
|Estimated Primary Completion Date :||January 1, 2024|
|Estimated Study Completion Date :||January 1, 2034|
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
56 mg/m2 IV given on days 1, 8, and 15 of each cycle during induction and consolidation phases of the study.
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.
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.
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): NCT03289299
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|United States, Indiana|
|Indiana University Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Kansas|
|University of Kansas Cancer Center|
|Westwood, Kansas, United States, 66205|
|United States, Maryland|
|University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Weill Cornell Medicine|
|New York, New York, United States, 10022|
|United States, North Carolina|
|Levine Cancer Institute|
|Charlotte, North Carolina, United States, 28204|
|United States, Washington|
|Swedish Cancer Institute|
|Seattle, Washington, United States, 98104|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Shaji Kumar, MD||Mayo Clinic|
|Principal Investigator:||Brian Durie, MD||International Myeloma Foundation|