Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 53
Healthy volunteers: no

Brief summary:
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may kill more cancer cells.\> PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with newly diagnosed multiple myeloma.

Detailed description:
OBJECTIVES:

Primary

\* Assess the response rate in patients with newly diagnosed active multiple myeloma treated with lenalidomide, cyclophosphamide, and dexamethasone.

Secondary

* Assess the toxicity of this regimen in these patients.
* Determine the time to progression in patients treated with this regimen. OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide on days 1, 8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

Arms:
arm 1: None

Interventions: intervention 1: cyclophosphamide intervention 2: dexamethasone intervention 3: lenalidomide
Intervention descriptions: intervention 1: 300 mg/m2 administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles) OR 300 mg administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles) intervention 2: 40 mg administrated by PO (with food)on Days 1, 8, 15 \& 22 intervention 3: 25 mg administrated by PO (with food)on Days 1-21

Protocol document: