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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	18 March 2013
Main ID:	EUCTR2008-001405-41-DE
Date of registration:	28/08/2008
Prospective Registration:	Yes
Primary sponsor:	GMIHO mbH
Public title:	A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX
Scientific title:	A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX
Date of first enrolment:	24/10/2008
Target sample size:
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001405-41
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Germany

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
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Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

AL amyloidosis

Intervention(s)

Trade Name: Revlimid
Pharmaceutical Form: Capsule*
Other descriptive name: Lenalidomide
Concentration unit: IU/mg international unit(s)/milligram
Concentration number: 5 mg-

Trade Name: Alkeran
Product Code: L01AA03
Pharmaceutical Form: Film-coated tablet
Other descriptive name: melphalan
Concentration unit: IU/mg international unit(s)/milligram
Concentration number: 2 mg-

Trade Name: Fortecortin
Pharmaceutical Form: Tablet
Other descriptive name: dexamethasone
Concentration unit: IU/mg international unit(s)/milligram
Concentration number: 4 mg-

Primary Outcome(s)

Main Objective: Evaluate rate of complete remission

Secondary Objective: toxicity, rate of haematological response and organ response, correlation of cytogenetic aberrations and GEP results with haematological response, retrospective comparison with historical controls treated with M-Dex

Primary end point(s): CR rate after 6 cycles of L-M-Dex

Secondary Outcome(s)

Secondary ID(s)

GMIHO-005/2007 (191063)

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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