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

This study has been completed.
Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
Information provided by (Responsible Party):
Dr. Stefan Schönland, University of Heidelberg Identifier:
First received: April 15, 2009
Last updated: November 21, 2013
Last verified: November 2013
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 Intervention Phase
Primary Amyloidosis Drug: Lenalidomide Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Dr. Stefan Schönland, University of Heidelberg:

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

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

Enrollment: 50
Study Start Date: April 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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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Please refer to this study by its identifier: NCT00883623

University Clinic Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
Principal Investigator: Stefan Schoenland, MD University Clinic Heidelberg - Department of Internal Medicine V
  More Information

Additional Information:
Responsible Party: Dr. Stefan Schönland, MD, University of Heidelberg Identifier: NCT00883623     History of Changes
Other Study ID Numbers: 2008-001405-41
GMIHO 005/2007 (191063)
Study First Received: April 15, 2009
Last Updated: November 21, 2013

Keywords provided by Dr. Stefan Schönland, University of Heidelberg:

Additional relevant MeSH terms:
Proteostasis Deficiencies
Metabolic Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents processed this record on September 21, 2017