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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00679367
First Posted: May 16, 2008
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vaishali Sanchorawala, Boston Medical Center
  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: Intervention Model: Single Group Assignment
Masking: None (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 Vaishali Sanchorawala, Boston Medical Center:

Primary Outcome Measures:
  • Number of Participants With Hematologic Response [ Time Frame: one year ]

    Complete hematologic response: Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, bone marrow biopsy with less than 5% plasma cells without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.

    Partial hematologic response: Amyloid patients have highly individualized measures of disease burden. For patients with detectable and quantifiable monoclonal marrow plasmacytosis, a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis, a reduction in the peak height of 50% or more. For patients with quantifiable urinary kappa or lambda chain concentration, a 50% reduction in daily light chain excretion (concentration x 24 hour urine volume). For patients with an elevated serum free light chain assay, reduction of 50% or more.



Secondary Outcome Measures:
  • Number of Organs Improved or Stable Based on Description Below: [ Time Frame: one year ]

    Renal response - > 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency.

    Hepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline.

    Cardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness > 11 mm or a decrease in New York Heart Association heart failure class.

    Autonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus.

    Gastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid.

    Peripheral nervous system response - resolution of clinical signs of peripheral neuropathy.


  • Number of Participants Removed From Study Due to Toxicities [ Time Frame: One year ]
    Number of study participants removed from study treatment due to toxicities


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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679367


Locations
United States, Massachusetts
Boston University Cancer Research Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Vaishali Sanchorawala, MD Boston Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vaishali Sanchorawala, Principal Investigator, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00679367     History of Changes
Other Study ID Numbers: CDR0000595759
RV-AMYL-PI-0219 ( Other Grant/Funding Number: Celgene )
BUMC-H-26320 ( Other Identifier: Boston University Medical Center IRB )
First Submitted: May 14, 2008
First Posted: May 16, 2008
Results First Submitted: September 9, 2016
Results First Posted: February 20, 2017
Last Update Posted: February 20, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Vaishali Sanchorawala, 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
Lenalidomide
Thalidomide
Melphalan
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids