Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia

NCT02302469 | Completed Phase 1 DMC

• 2 other identifiers: 2008_15/08372008-006370-15
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to determine the recommended dose of lenalidomide in subjects with relapse and refractory Waldenstrom Macroglobulinemia.

Conditions

Waldenstrom Macroglobulinemia

Keywords

Lenalidomide; Hematology; Waldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

• Number of Participants with dose limiting toxicities (DLT) of lenalidomide as a Measure of Safety and Tolerability.

  To determine the recommended dose of lenalidomide in subjects with relapse and refractory Waldenstrom Macroglobulinemia

  1 month

Secondary Outcomes (5)

• number of patients with a response to lenalidomide

  60 months

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  60 months

• Measurements of free light chain assays.

  Baseline, 2 months, 3 months

• Response duration.

  60 months

• progression free survival

  60 months

Study Arms (1)

revlimid

OTHER

a dose-escalation of revlimid

Drug: Revlimid

Interventions

Revlimid DRUG

Three cohorts of subjects will be successively exposed to escalating doses of Lenalidomide (15, 20 and 25mg once daily on days 1-21 of a 28 day cycle).

Also known as: lénalidomide

revlimid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The most important criteria for patient eligibility include:
• Age \>=18 years
• Patients must have received prior therapy (any number of therapies) for WM and have relapsed or refractory WM
• Eastern Cooperative Oncology Group performance score of 0 - 2
• Hemoglobin \>= 10g/dL or hematocrit \>= 30%
• Absolute neutrophil count (ANC) \>1000/mm3 and platelet count \>75,000/mm3
• 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
• Evaluable immunochemical abnormalities including abnormal electrophoresis and serum free light chain assay with an increase of either kappa or lambda light chain lev -

You may not qualify if:

• Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation
• Patients treated or requiring corticosteroids \>30mg/day
• Pregnant or breast feeding females (Lactating females must agree not to breast feed while taking lenalidomide)
• Use of any other experimental drug or therapy within 28 days of baseline
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
• Known positive for HIV or infectious hepatitis, type A, B or C -

Sponsors & Collaborators

• University Hospital, Lille: lead
• Celgene Corporation: collaborator

Study Sites (7)

Centre Hospitalier de la côte basque

Bayonne, 64109, France

Location

Ch Clermond Ferrand

Clermont-Ferrand, 63000, France

Location

CH LENS

Lens, 62307, France

Location

Chru Lille

Lille, 59037, France

Location

Ch Nantes

Nantes, 44 093, France

Location

Groupe hospitalier Pitié Salpétrière

Paris, 75651, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Related Publications (1)

• Fouquet 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 RESULT

Related Links

• European Clinical Trials Register

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• TOURNILLAC Olivier, Dr

  Centre Hospitalier CLERMOND FERRAND

  PRINCIPAL INVESTIGATOR

• MOREL Pierre, Dr

  Centre Hospitalier de Lens

  PRINCIPAL INVESTIGATOR

• LELEU Xavier, Dr

  CHRU LILLE

  STUDY DIRECTOR

• LEGOUILL Steven, Dr

  Centre Hospitalier de NANTES

  PRINCIPAL INVESTIGATOR

• LEBLOND Véronique, Dr

  APHP PARIS

  PRINCIPAL INVESTIGATOR

• BANOS Anne, Dr

  Centre Hospitalier de BAYONNE

  PRINCIPAL INVESTIGATOR

• SALLES Gilles, Pr

  Centre Hospitalier de LYON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: November 27, 2014
• Study Start: March 1, 2009
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)