Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis - Full Text View

Sponsored by:	Boston Hematology Oncology
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00679367

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 II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Melphalan Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Melphalan hydrochloride Sarcolysin Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	A Phase II Trial of MRD (Melphalan, Lenalidomide and Dexamethasone) for Patients With AL Amyloidosis

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Hematologic response rate as measured by standard criteria [ Designated as safety issue: No ]
Safety (i.e., type, frequency, severity, and relationship of adverse events to study treatment) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Organ response [ Designated as safety issue: No ]

Estimated Enrollment:	35
Study Start Date:	May 2008
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

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 Hematology Oncology	Recruiting
Boston, Massachusetts, United States, 02120
Contact: David C. Seldin, MD, PhD 617-638-8265

Sponsors and Collaborators

Boston Hematology Oncology

Investigators

Principal Investigator:

David C. Seldin, MD, PhD

Boston Hematology Oncology

More Information

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

Responsible Party:	Boston University Cancer Research Center ( David C. Seldin )
Study ID Numbers:	CDR0000595759, BHO-H-26320, BHO-RV0219, BUMC-H-26320
Study First Received:	May 14, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00679367
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

primary systemic amyloidosis

Study placed in the following topic categories:

Dexamethasone
Melphalan
Metabolic Diseases
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Primary Amyloidosis
Blood Coagulation Disorders
Lenalidomide
Vascular Diseases

Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Amyloidosis
Hemorrhagic Disorders
Multiple myeloma
Metabolic disorder
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Immunosuppressive Agents

Hormones
Glucocorticoids
Pharmacologic Actions
Neoplasms
Autonomic Agents
Therapeutic Uses
Myeloablative Agonists
Cardiovascular Diseases
Antineoplastic Agents, Alkylating
Peripheral Nervous System Agents
Alkylating Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009