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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of primary systemic amyloidosis

- No secondary or familial amyloidosis

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

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

- No prior cumulative doses of oral melphalan > 200 mg

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

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Hematologic response rate as measured by standard criteria

Outcome Description:

measured by standard criteria

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

David C. Seldin, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000595759

NCT ID:

NCT00679367

Start Date:

May 2008

Completion Date:

May 2030

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • primary systemic amyloidosis
  • Amyloidosis
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

Boston University Cancer Research CenterBoston, Massachusetts  02118