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A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis (LEOMEX)

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ClinicalTrials.gov Identifier: NCT00883623
Recruitment Status : Completed
First Posted : April 17, 2009
Last Update Posted : November 25, 2013
Sponsor:
Collaborator:
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Information provided by (Responsible Party):
Dr. Stefan Schönland, Heidelberg University

Study Description
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Brief Summary:
The treatment with oral melphalan and prednisone has been recommended as standard treatment of AL amyloidosis but the results are rather disappointing. Another therapeutic option is pulsed high-dose dexamethasone + melphalan (Mel-Dex) with more encouraging results regarding the achievement of a faster disease response and higher rates of haematological remission. In the last 5 - 10 years, promising treatment outcomes after therapy with high-dose melphalan and autologous stem cell support have been reported by several groups but only highly selected patients are eligible for this treatment. Lenalidomide has been shown to be effective in phase II and III trials in MM patients. Because of the relationship to MM, Lenalidomide is a promising therapeutic option also for patients with AL amyloidosis. The addition of Lenalidomide to Mel-Dex could improve rate of complete response (CR) and organ response in patients not eligible for or refused high-dose chemotherapy.

Condition or disease Intervention/treatment Phase
Primary Amyloidosis Drug: Lenalidomide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Single Center Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With AL Amyloidosis
Study Start Date : April 2009
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm
Treatment Arm
 Drug: Lenalidomide
Up to 6 cycles of oral L-Mel-Dex, every 28 days Revlimid® 10 mg daily for 21 days, (add on therapy), Melphalan 0.15 mg/kg/day day 1-4, Dexamethasone 20 mg day 1-4
Other Name: Revlimid


Outcome Measures
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Primary Outcome Measures :
  1. Complete response (CR) rate [ Time Frame: 6 months: after 6 cycles of L-Mel-Dex ]

Secondary Outcome Measures :
  1. Rate of hematological response (CR and PR) [ Time Frame: 6 months ]
  2. Organ response rate [ Time Frame: 3 months after discontinuation of L-Mel_Dex (maximum: 9 months) ]
  3. Correlation of cytogenetic aberrations and gene expression profiling (GEP) results with best hematological response to treatment [ Time Frame: 6 months ]
  4. Retrospective comparison with a historical control group treated with Mel-Dex in our institution [ Time Frame: 01.04.2012 ]
  5. Toxicity (hematological and non-hematological) [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven systemic untreated AL amyloidosis requiring systemic chemotherapy
  • Not eligible for or refused HDM
  • Measurable plasma cell disease
  • Life expectancy > 3 months
  • WHO performance status < 3
  • NYHA < stage IV
  • Understand and voluntarily sign an informed consent form
  • Laboratory test results within these ranges Absolute neutrophil count > 1.5 x 109/L Platelet count > 100 x 109/L Creatinine Clearance / MDRD > 40 ml/min Total bilirubin > 2,5 mg/dL
  • Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study.

Exclusion Criteria:

  • Multiple Myeloma stage II and III (Durie and Salmon)
  • Previous organ transplantation
  • Not able to visit the Amyloid Clinic in Heidelberg once per month
  • Refusal of aspiration of 100 ml bone marrow at study inclusion
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  • Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
  • Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
  • Use of any other experimental drug or therapy within 28 days of baseline.
  • Known hypersensitivity to thalidomide.
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
  • Any prior use of lenalidomide.
  • Concurrent use of other anti-cancer agents or treatments.
  • Known positive for HIV or infectious hepatitis, B or C.
  • Patients who are in a depending position of the Sponsor or the Principal Investigator
Contacts and Locations
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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): NCT00883623


Locations
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Germany
University Clinic Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Investigators
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Principal Investigator: Stefan Schoenland, MD University Clinic Heidelberg - Department of Internal Medicine V
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Stefan Schönland, MD, Heidelberg University
ClinicalTrials.gov Identifier: NCT00883623    
Other Study ID Numbers: 2008-001405-41
GMIHO 005/2007 (191063)
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Dr. Stefan Schönland, Heidelberg University:
AL-Amyloidosis
Lenalidomide
Additional relevant MeSH terms:
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Immunoglobulin Light-chain Amyloidosis
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
 Paraproteinemias
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents