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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00679367
First received: May 14, 2008
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
 Drug: dexamethasone
Drug: lenalidomide
Drug: melphalan
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Hematologic response rate as measured by standard criteria [ Time Frame: one year ] [ Designated as safety issue: No ]
    measured by standard criteria

  • Safety (i.e., type, frequency, severity, and relationship of adverse events to study treatment) [ Time Frame: within 100 days of infusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Organ response [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: May 2008
Estimated Study Completion Date: May 2030
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: dexamethasone
    40 mg/QD once weekly
    Other Name: Decadron
    Drug: lenalidomide
    10 mg/day D1-21
    Other Name: revlimid, cc-5013
    Drug: melphalan
    5 mg/m2 D1-4
    Other Name: alkeran
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679367

Locations
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: David C. Seldin, MD, PhD Boston Medical Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided by Boston Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00679367     History of Changes
Other Study ID Numbers: CDR0000595759, BHO-H-26320, BHO-RV0219, BUMC-H-26320
Study First Received: May 14, 2008
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Medical Center:
primary systemic amyloidosis

Additional relevant MeSH terms:
Amyloidosis
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Proteostasis Deficiencies
Metabolic Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
 Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Melphalan
Thalidomide
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on June 18, 2013