Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis (MRD)
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| ClinicalTrials.gov Identifier: NCT00679367 |
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Recruitment Status :
Completed
First Posted : May 16, 2008
Results First Posted : February 20, 2017
Last Update Posted : February 20, 2017
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Drug: dexamethasone Drug: lenalidomide Drug: melphalan | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 16 participants |
| Allocation: | N/A |
| 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 |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | May 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Melphalan Revlimid and Dexamethasone
Melphalan Lenalidomide Dexamethasone
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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 |
- 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.
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
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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
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
| United States, Massachusetts | |
| Boston University Cancer Research Center | |
| Boston, Massachusetts, United States, 02118 | |
| Principal Investigator: | Vaishali Sanchorawala, MD | Boston Medical Center |
| Responsible Party: | Vaishali Sanchorawala, Principal Investigator, Boston Medical Center |
| ClinicalTrials.gov Identifier: | NCT00679367 |
| 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 Posted: | May 16, 2008 Key Record Dates |
| 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 |
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primary systemic amyloidosis |
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Multiple Myeloma Immunoglobulin Light-chain Amyloidosis 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 Lenalidomide Melphalan Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |