Back to resultsA Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis (LEOMEX)
Primary Purpose
Primary Amyloidosis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Primary Amyloidosis focused on measuring AL-Amyloidosis, Lenalidomide
Eligibility 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
Sites / Locations
- University Clinic Heidelberg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
Treatment Arm
Outcomes
Primary Outcome Measures
Complete response (CR) rate
Secondary Outcome Measures
Rate of hematological response (CR and PR)
Organ response rate
Correlation of cytogenetic aberrations and gene expression profiling (GEP) results with best hematological response to treatment
Retrospective comparison with a historical control group treated with Mel-Dex in our institution
Toxicity (hematological and non-hematological)
Full Information
NCT ID
NCT00883623
First Posted
April 15, 2009
Last Updated
November 21, 2013
Sponsor
Heidelberg University
Collaborators
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
1. Study Identification
Unique Protocol Identification Number
NCT00883623
Brief Title
A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis
Acronym
LEOMEX
Official Title
A Prospective Single Center Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With AL Amyloidosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Amyloidosis
Keywords
AL-Amyloidosis, Lenalidomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Treatment Arm
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete response (CR) rate
Time Frame
6 months: after 6 cycles of L-Mel-Dex
Secondary Outcome Measure Information:
Title
Rate of hematological response (CR and PR)
Time Frame
6 months
Title
Organ response rate
Time Frame
3 months after discontinuation of L-Mel_Dex (maximum: 9 months)
Title
Correlation of cytogenetic aberrations and gene expression profiling (GEP) results with best hematological response to treatment
Time Frame
6 months
Title
Retrospective comparison with a historical control group treated with Mel-Dex in our institution
Time Frame
01.04.2012
Title
Toxicity (hematological and non-hematological)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Schoenland, MD
Organizational Affiliation
University Clinic Heidelberg - Department of Internal Medicine V
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
28522573
Citation
Hegenbart U, Bochtler T, Benner A, Becker N, Kimmich C, Kristen AV, Beimler J, Hund E, Zorn M, Freiberger A, Gawlik M, Goldschmidt H, Hose D, Jauch A, Ho AD, Schonland SO. Lenalidomide/melphalan/dexamethasone in newly diagnosed patients with immunoglobulin light chain amyloidosis: results of a prospective phase 2 study with long-term follow up. Haematologica. 2017 Aug;102(8):1424-1431. doi: 10.3324/haematol.2016.163246. Epub 2017 May 18.
Results Reference
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A Trial of Treatment With Lenalidomide-Melphalan-Dexamethasone in Patients With Primary (AL) Amyloidosis
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