Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: primary systemic amyloidosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 35
Healthy volunteers: no

Brief summary:
RATIONALE: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop plasma cells from growing. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of plasma cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may be an effective treatment for primary systemic amyloidosis.

PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with primary systemic amyloidosis.

Detailed description:
OBJECTIVES:

Primary

\* Assess the hematologic response rate in patients with primary systemic amyloidosis treated with lenalidomide, cyclophosphamide, and dexamethasone.

Secondary

* Determine the organ response rate in patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine the time to progression in patients treated with this regimen.
* Determine the survival of 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. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: \*Patients may receive cyclophosphamide for up to 1 year. After completion of study treatment, patients are followed every 6 months for up to 3 years.

Arms:
arm 1: Lenalidomide 15mg daily (days 1-21)

Cyclophosphamide 300 mg/m\^2 (days 1, 8, 15)

Dexamethasone 40 mg weekly

Interventions: intervention 1: cyclophosphamide intervention 2: dexamethasone intervention 3: lenalidomide
Intervention descriptions: intervention 1: 300 mg/m\^2 days 1, 8 \& 15 of a 28 day cycle taken orally with food intervention 2: 40 mg weekly taken orally intervention 3: 15 mg daily days 1-21 of a 28 day cycle taken orally with food

Protocol document: