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A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX

A prospective trial of treatment with Lenalidomide-Melphalan-Dexamethason (L-Mel-Dex) in untreated patients with AL amyloidosis (LEOMEX) - LEOMEX

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001405-41-DE
Enrollment
Unknown
Registered
2008-08-28
Start date
2008-10-24
Completion date
Unknown
Last updated
2013-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AL amyloidosis

Interventions

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 Produ

Sponsors

GMIHO mbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 26, 2026