Study of Single Agent Lenalidomide in Older Adults With Newly Diagnosed Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

January 14, 2010

Primary Completion Date

August 31, 2020

Study Completion Date

November 24, 2020

Conditions
Multiple Myeloma
Interventions
DRUG

Lenalidomide

"* Starting Dose: 25 mg by mouth (PO) days 1-21 of a 28 days cycle;~* Dose Level -1: 15 mg PO days 1-21 of a 28 days cycle;~* Dose Level -2: 10 mg PO days 1-21 of a 28 days cycle;~* Dose Level -3: 5 mg PO days 1-21 of a 28 days cycle;~* Dose Level -4: Discontinue"

DRUG

Prednisone

"* Starting Dose: 100 mg PO days 1-5 every 28 days;~* Dose level -1: 50 mg PO days 1-5 of a 28 day cycle;~* Dose level -2: 25 mg PO days 1-5 of a 28 day cycle;~* Dose level -3: Discontinue"

DRUG

Dexamethasone

"* Starting Dose: 40 mg daily on days 1 - 4 every 28 days;~* Dose level -1: 20 mg daily on days 1 - 4 every 28 days;~* Dose level -1a: 40 mg daily on days 1, 2, and 3 followed by 20 mg on day 4 followed by 12 mg on day 5 followed by 8 mg on day 6;~* Dose level -2: 10 mg daily on days 1 - 4 every 28 days;~* Dose level -3: Discontinue"

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER