Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

April 11, 2017

Study Completion Date

April 11, 2017

Conditions
Multiple Myeloma
Interventions
PROCEDURE

Autologous peripheral blood stem cell transplant

Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.

DRUG

Lenalidomide

Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.

DRUG

Dexamethasone

Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.

PROCEDURE

Stem cell collection

Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is \>2500 x 109 cells/liter; platelet count is \>20 x 103/mm3.

DRUG

Melphalan

Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.

DRUG

G-CSF

Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.

DRUG

Cyclophosphamide

Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.

DRUG

Mesna

Mesna will be provided with the cyclophosphamide.

Trial Locations (1)

10032

Columbia University, New York

All Listed Sponsors
lead

Columbia University

OTHER

NCT01731886 - Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma | Biotech Hunter | Biotech Hunter