Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance

PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

October 28, 2011

Primary Completion Date

March 19, 2021

Study Completion Date

March 19, 2021

Conditions
Multiple Myeloma
Interventions
DRUG

lenalidomide

patients will begin therapy with lenalidomide 25 mg daily, 21 days out of a 28 day schedule. All patients will be evaluated monthly after every cycle. The dose will be adjusted downward in response to side effects and according to specific guidelines. Symptomatic POD occurring at any time during the study will result in removal of the patient from the study. After 2 cycles of lenalidomide, patients with at least stable disease (SD) will continue lenalidomide indefinitely until asymptomatic POD, at which time dexamethasone will be added at a dose of 40mg weekly. On the other hand, patient with asymptomatic POD after 2 cycles of lenalidomide will have dexamethasone added at a dose of 40 mg weekly. Patients with any type of POD after any cycle that includes dexamethasone will be taken off study. Patients can remain on study on lenalidomide or lenalidomide/dexamethasone indefinitely as long as they do not have POD as stated above and they tolerate the treatment.

Trial Locations (11)

10065

Memorial Sloan Kettering Cancer Center, New York

Weill Cornell Medical Center, New York

10467

Montefiore Medical Center, The Bronx

10591

Memoral Sloan Kettering Cancer Center at Phelps, Sleepy Hollow

11040

North Shore LIJ, New Hyde Park

06902

Stamford Hospital, Stamford

07920

Memorial Sloan Kettering at Basking Ridge, Basking Ridge

Unknown

Memoral Sloan Kettering Cancer Center, Basking Ridge

SUNY Downstate Medical Center, Brooklyn

University of Rochester Medical Center, Rochester

Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre

All Listed Sponsors
collaborator

Montefiore Medical Center

OTHER

collaborator

State University of New York - Downstate Medical Center

OTHER

collaborator

University of Rochester

OTHER

collaborator

Weill Medical College of Cornell University

OTHER

collaborator

Stamford Hospital

OTHER

collaborator

Columbia University

OTHER

collaborator

State University of New York - Upstate Medical University

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT01463670 - Lenalidomide Intensification in Patients With Serologic/Asymptomatic Progression of Multiple Myeloma While on Lenalidomide Maintenance | Biotech Hunter | Biotech Hunter