Clinical trial · Interventional
Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia
A Multicenter Phase I/II Dose Escalation Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia
NCT02302469CI-TRIAL-00098073RV-WM-0426completedPhase 1 / Phase 2ClinicalTrials.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)
The purpose of this study is to determine the recommended dose of lenalidomide in subjects with relapse and refractory Waldenstrom Macroglobulinemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Waldenstrom Macroglobulinemia | Waldenstrom Macroglobulinemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Revlimid | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- revlimid
- description
- a dose-escalation of revlimid
- interventionNames
- Drug: Revlimid
Primary outcomes (1)
- measure
- Number of Participants with dose limiting toxicities (DLT) of lenalidomide as a Measure of Safety and Tolerability.
- timeFrame
- 1 month
- description
- To determine the recommended dose of lenalidomide in subjects with relapse and refractory Waldenstrom Macroglobulinemia
Secondary outcomes (5)
- measure
- number of patients with a response to lenalidomide
- timeFrame
- 60 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: The most important criteria for patient eligibility include: 1. Age \>=18 years 2. Patients must have received prior therapy (any number of therapies) for WM and have relapsed or refractory WM 3. Eastern Cooperative Oncology Group performance score of 0 - 2 4. Hemoglobin \>= 10g/dL or hematocrit \>= 30% 5. Absolute neutrophil count (ANC) \>1000/mm3 and platelet count \>75,000/mm3 6. Adequate organ function defined as * serum glutamate pyruvate transaminase and serum glutamate oxaloacetate transaminase \< 2 x International Unit/l * Total bilirubin \>= 1.5 mg/dL * Clearance creatinin \> 50 ml/mn 7. Evaluable immunochemical abnormalities including abnormal electrophoresis and serum free light chain assay with an increase of either kappa or lambda light chain lev - Exclusion Criteria: Key Exclusion criteria 1. Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation 2. Patients treated or requiring corticosteroids \>30mg/day 3. Pregnant or breast feeding females (Lactating females must agree not to breast feed while taking lenalidomide) 4. Use of any other experimental drug or therapy within 28 days of baseline 5. The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs 6. Known positive for HIV or infectious hepatitis, type A, B or C -
References
Publications (1)
- RESULTFouquet G, Guidez S, Petillon MO, Louni C, Ohyba B, Dib M, Poulain S, Herbaux C, Martin A, Thielemans B, Brice P, Choquet S, Bakala J, Bories C, Demarquette H, Nudel M, Tournilhac O, Arnulf B, LeGouill S, Morel P, Banos A, Karlin L, Salles G, Leblond V, Leleu X. Lenalidomide is safe and active in Waldenstrom macroglobulinemia. Am J Hematol. 2015 Nov;90(11):1055-9. doi: 10.1002/ajh.24175. Epub 2015 Oct 6. PMID 26284823