A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX
- Conditions
- AL amyloidosis
- Registration Number
- EUCTR2008-001405-41-DE
- Lead Sponsor
- GMIHO mbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
-Untreated patients with systemic AL amyloidosis
-Age between 18 and 74 years
-Not eligible for or refused high-dose chemotherapy
-NYHA stage < IV
-Measurable plasma cell disorder
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-Multiple myeloma stage II and III
-Not able to visit the Amyloidosis Clinic in Heidelberg once per months
-Pregnant or breast feeding females
-Not able to give informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method