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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00883623
First Posted: April 17, 2009
Last Update Posted: November 25, 2013
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.
Collaborator:
Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
Information provided by (Responsible Party):
Dr. Stefan Schönland, University of Heidelberg
April 15, 2009
April 17, 2009
November 25, 2013
April 2009
February 2013   (Final data collection date for primary outcome measure)
Complete response (CR) rate [ Time Frame: 6 months: after 6 cycles of L-Mel-Dex ]
Same as current
Complete list of historical versions of study NCT00883623 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 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 ]
Not Provided
Not Provided
 
A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis
A Prospective Single Center Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With AL Amyloidosis
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Primary Amyloidosis
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
Experimental: Treatment Arm
Treatment Arm
Intervention: Drug: Lenalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00883623
2008-001405-41
GMIHO 005/2007 (191063)
Yes
Not Provided
Not Provided
Dr. Stefan Schönland, University of Heidelberg
Heidelberg University
Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH
Principal Investigator: Stefan Schoenland, MD University Clinic Heidelberg - Department of Internal Medicine V
Heidelberg University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP