Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

April 26, 2016

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2026

Conditions
Multiple Myeloma
Interventions
DRUG

Lenalidomide

"* Cycle 1: 15 mg days 1-21~* Cycles 2-4: 25 mg days 1-21 if tolerated, otherwise continue at lower dose~* Cycles 5 and beyond: best tolerated dose days 1-21"

DRUG

Carfilzomib

"* Cycle 1: 20 mg/m2 Days 1, 2; 36 mg/m2 Days 8, 9, 15, 16. Alternatively, intermediate dose escalation (to 27mg/m2 on days 8,9 of cycle 1) will be al12,lowed at the treating physician's discretion.~* Cycle 2-4: 36 mg/m2 if tolerated Days 1, 2, 8, 9, 15, 16~* Cycles 5-8 (patients that are MRD- and have no risk factors at the end of cycle 6) and Cycle 5 - 36 (for MRD+ patients and high risk patients at the end of cycle 6): best tolerated dose Days 1, 2, 15, 16"

DRUG

Dexamethasone

"* Cycles 1 - 4: 20 mg PO or IV per dose Days 1, 8, 15, 22~* Cycles 5+: 20 mg or best tolerated dose PO or IV per dose Days 1, 8, 15, 22"

DRUG

Lenalidomide (Control)

"* Cycles 1-4: Days 1-28. Lenalidomide will begin at a dose of 10 mg PO daily (2 capsules per day). After three months, the dose will be increased, provided ANC ≥ 1,000/µL, platelet count ≥ 75,000/µL, and all nonhematologic toxicity is ≤ grade 1, to 15 mg PO daily (3 capsules per day).~* Cycles 5 and beyond: best tolerated dose days 1-28"

Trial Locations (3)

48201

Wayne State University - Karmanos Cacner Institute, Detroit

60637

University of Chicago, Chicago

Unknown

Polish Myeloma Consortium, Poznan

All Listed Sponsors
lead

University of Chicago

OTHER

NCT02659293 - Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma | Biotech Hunter | Biotech Hunter