Conditions: Multiple Myeloma Non-Hodgkin's Lymphoma
Keywords: LENALIDOMIDE (CC-5013) Romidepsin (Istodax) 12-170
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 49
Healthy volunteers: no

Brief summary:
The treatments used to treat lymphoma and multiple myeloma sometimes do not always work well or they may only work for a short period of time. This is why new treatments are being tested.

This study will test a new combination of two drugs that are already approved by the Food and Drug Administration for treatment of certain kinds of blood cancers. These drugs are romidepsin and lenalidomide. Both these drugs by themselves have been used to treat lymphoma or multiple myeloma. However, while these drugs are routinely used alone, this is the first time they will be tested together. The mechanism of action of both drugs is not well understood but both have been shown to to be effective by themselves in lymphoma and multiple myeloma.

Detailed description:

Arms:
arm 1: This will be a multicentered, open label, phase Ib/IIa trial of romidepsin and lenalidomide in patients with relapsed or refractory lymphomas or multiple myeloma. Lenalidomide will be provided in accordance with the Celgene Corporation's Revlimid REMS® program. Per standard Revlimid REMS® program requirements, all physicians who prescribe lenalidomide for research subjects enrolled into this trial, and all research subjects enrolled into this trial, must be registered in, and must comply with, all requirements of the Revlimid REMS® program. Only enough lenalidomide for one cycle of therapy will be supplied to the patient each cycle.

Interventions: intervention 1: Romidepsin intervention 2: Lenalidomide
Intervention descriptions: intervention 1: Romidepsin will be administered intravenously on days 1, 8, and 15 of a 28-day cycle. intervention 2: Lenalidomide will be taken orally daily for 21 days of a 28-day cycle.

Protocol document:
Prot_SAP_000.pdf: