Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

May 25, 2018

Primary Completion Date

September 26, 2023

Study Completion Date

November 15, 2031

Conditions
Smoldering Multiple Myeloma
Interventions
DRUG

Carfilzomib

56 mg/m2 IV given on days 1, 8, and 15 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."

DRUG

Daratumumab

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

Trial Locations (10)

10022

Weill Cornell Medicine, New York

21201

University of Maryland Medical Center, Baltimore

28204

Levine Cancer Institute, Charlotte

33612

Moffitt Cancer Center, Tampa

46202

Indiana University Simon Cancer Center, Indianapolis

53226

Medical College of Wisconsin, Milwaukee

55905

Mayo Clinic, Rochester

60637

University of Chicago Medical Center, Chicago

66205

University of Kansas Cancer Center, Westwood

98104

Swedish Cancer Institute, Seattle

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

collaborator

Celgene

INDUSTRY

collaborator

Trevie, Inc.

UNKNOWN

lead

International Myeloma Foundation

OTHER

NCT03289299 - Aggressive Smoldering Curative Approach Evaluating Novel Therapies and Transplant | Biotech Hunter | Biotech Hunter