Clinical trial · Interventional
A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis
NCT00890552CI-TRIAL-00026565completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This open-label trial will evaluate the use of lenalidomide; melphalan; and dexamethasone (MDR) to treat newly diagnosed or relapsed AL amyloidosis, over the course of nine 28-day cycles.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Amyloidosis | Amyloidosis | ONTOLOGY_EXACT | 0.98 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide+Melphalan+Dexamethasone
- description
- Patients received lenalidomide 10 mg/day orally on days 1-21, melphalan 0.18 mg/kg orally on days 1-4, and dexamethasone 40 mg orally once weekly of a 28-day cycle (MDR treatment).
- interventionNames
- Drug: Lenalidomide
- Drug: Melphalan
- Drug: Dexamethasone
Primary outcomes (1)
- measure
- Hematologic Response Rate
- timeFrame
- 8 weeks
- description
- At the end of each treatment cycle (4 weeks), hematologic response rate as assessed. Hematologic response was considered to be amyloid complete response (normal FLC ratio and negative serum and urine immunofixation); very good partial response (difference between involved and uninvolved FLCs \[dFLC\] \< 40 mg/L); or partial response (dFLC decrease \> 50%).
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA * Newly diagnosed or relapsed AL amyloidosis * Biopsy-proven amyloidosis with evidence of an underlying plasma cell dyscrasia * abnormal clonal dominance of plasma cells in the bone marrow * detection of a monoclonal gammopathy by immunofixation electrophoresis of serum and/or urine * an abnormal serum free light chain or ratio, or AL fibrils seen on biopsy) * Measurable disease defined by an abnormal serum-free light chain or monoclonal protein by immunofixation * proteinuria ≥ 0.5 g/day, cardiac involvement with interventricular septal thickness ≥ 15 mm * hepatomegaly in the absence of congestive heart failure with elevated alkaline phosphatase * Age ≥ 18 years at the time of signing the informed consent form. * All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study * ECOG performance status of ≤ 3 at study entry * Laboratory test results: * Absolute neutrophil count ≥ 1.0 x 10e9 / L * Platelet count ≥ 75 x 10e9 / L * Creatinine clearance ≥ 15 mL/ minute * Total bilirubin ≤ 2-fold upper limits of normal * Disease-free of prior malignancies (excluding multiple myeloma) for ≥ 3 years with exception of: * currently treated basal cell * squamous cell carcinoma of the skin * carcinoma "in situ" of the cervix or breast. * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test * Females of childbearing potential must either: * commit to continued abstinence from heterosexual intercourse * acceptable methods of birth control and agree to ongoing pregnancy testing * Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy * All study participants must be registered into the mandatory RevAssist program, and able to comply with its requirements * Able to take aspirin (81 mg) daily • Understand and voluntarily sign an informed consent form * Able to adhere to the study visit schedule and other protocol requirements EXCLUSION CRITERIA * Any serious medical condition that would prevent the subject from signing the informed consent form * Pregnant * breast-feeding females * Use of any other experimental drug or therapy within 28 days of baseline * Known hypersensitivity to thalidomide * 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 positivity for human immunodeficiency virus HIV)
References
Publications (2)
- BACKGROUNDPalladini G, Dispenzieri A, Gertz MA, Kumar S, Wechalekar A, Hawkins PN, Schonland S, Hegenbart U, Comenzo R, Kastritis E, Dimopoulos MA, Jaccard A, Klersy C, Merlini G. New criteria for response to treatment in immunoglobulin light chain amyloidosis based on free light chain measurement and cardiac biomarkers: impact on survival outcomes. J Clin Oncol. 2012 Dec 20;30(36):4541-9. doi: 10.1200/JCO.2011.37.7614. Epub 2012 Oct 22. PMID 23091105
- RESULTDinner S, Witteles W, Afghahi A, Witteles R, Arai S, Lafayette R, Schrier SL, Liedtke M. Lenalidomide, melphalan and dexamethasone in a population of patients with immunoglobulin light chain amyloidosis with high rates of advanced cardiac involvement. Haematologica. 2013 Oct;98(10):1593-9. doi: 10.3324/haematol.2013.084574. Epub 2013 May 28. PMID 23716538