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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Salli Fennessey, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00679367
First received: May 14, 2008
Last updated: March 16, 2016
Last verified: March 2016
  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
Drug: dexamethasone
Drug: lenalidomide
Drug: melphalan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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:


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


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

Enrollment: 16
Study Start Date: May 2008
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Melphalan Revlimid and Dexamethasone
Melphalan Lenalidomide Dexamethasone
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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Salli Fennessey, Study Coordinator, BUCRC, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00679367     History of Changes
Other Study ID Numbers: CDR0000595759  RV-AMYL-PI-0219  BUMC-H-26320 
Study First Received: May 14, 2008
Last Updated: March 16, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Medical Center:
primary systemic amyloidosis

Additional relevant MeSH terms:
Multiple Myeloma
Amyloidosis
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Proteostasis Deficiencies
Metabolic Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Lenalidomide
Melphalan
Thalidomide
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 24, 2016