NCT00564889

Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis

A Phase II Trial of Lenalidomide (Revlimid®), Cyclophosphamide and Dexamethasone in Patients With Primary Systemic Amyloidosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	cyclophosphamide	300 mg/m\^2 days 1, 8 \& 15 of a 28 day cycle taken orally with food
DRUG	dexamethasone	40 mg weekly taken orally
DRUG	lenalidomide	15 mg daily days 1-21 of a 28 day cycle taken orally with food

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-02-01
• Completion: 2012-06-01
• First posted: 2007-11-29
• Last updated: 2013-05-14
• Results posted: 2011-08-12

Locations

3 sites across 1 country: United States