Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L

PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

December 10, 2008

Primary Completion Date

July 31, 2018

Study Completion Date

July 31, 2018

Conditions
Multiple Myeloma
Interventions
PROCEDURE

Stem cell transplant x 1 or x 2

"After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.~On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L."

DRUG

lenalidomide and dexamethasone

Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center, New York

10591

Memoral Sloan Kettering Cancer Center at Phelps, Sleepy Hollow

Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow

10604

Memorial Sloan Kettering West Harrison, Harrison

11725

Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack

Unknown

Memoral Sloan Kettering Cancer Center, Basking Ridge

Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Tufts Medical Center

OTHER

collaborator

Lahey Clinic

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER