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

Multiple Myeloma Clinical Trial

— MRD  

Official title:

A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679367
• Other study ID #: CDR0000595759
• Secondary ID: RV-AMYL-PI-0219B
• Status: Completed
• Phase: Phase 2
• First received: May 14, 2008
• Last updated: March 16, 2016
• Start date: May 2008
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Description:

OBJECTIVES:

Primary

• To determine the tolerability and safety of melphalan, lenalidomide, and dexamethasone, in terms of toxicity, in patients with primary systemic amyloidosis.

• To determine the hematologic response rate in patients treated with this regimen.

Secondary

• To assess organ response in patients treated with this regimen.

OUTLINE: Patients receive oral lenalidomide once daily on days 1-21, oral melphalan once daily on days 1-4, and oral dexamethasone once on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months until disease progression and then annually thereafter.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

DISEASE CHARACTERISTICS:

• Diagnosis of primary systemic amyloidosis

PATIENT CHARACTERISTICS:

• Not pregnant

• Negative pregnancy test

• Able to tolerate an anticoagulation regimen (e.g., 325 mg of aspirin per day, therapeutic warfarin, or low molecular weight heparin)

PRIOR CONCURRENT THERAPY:

• Recovered from prior therapy

• Permanent or stable side effects/changes allowed

• Prior chemotherapy, thalidomide, lenalidomide, or steroids for amyloidosis allowed

• More than 4 weeks since prior and no other concurrent cytotoxic chemotherapy or radiotherapy

Exclusion Criteria:

• No secondary or familial amyloidosis

• No multiple myeloma (= 30% plasma cells in bone marrow biopsy or lytic bone lesions)

• No prior cumulative doses of oral melphalan > 200 mg

• No more than one prior course of high-dose melphalan with stem cell transplant

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amyloidosis
• Multiple Myeloma

Intervention

Drug:
• dexamethasone
40 mg/QD once weekly
• lenalidomide
10 mg/day D1-21
• melphalan
5 mg/m2 D1-4

Locations

Country	Name	City	State
United States	Boston University Cancer Research Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematologic response rate as measured by standard criteria	measured by standard criteria	one year	No
Secondary	Organ response		one year	No
Secondary	Safety (i.e., type, frequency, severity, and relationship of adverse events to study treatment)		within 100 days of infusion	Yes