New hope for rare blood cancer: lenalidomide dose study shows promise
NCT ID NCT02302469
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the drug lenalidomide in 17 people with Waldenstrom macroglobulinemia, a rare blood cancer, that had returned or stopped responding to prior treatments. The main goal was to find the safest dose by monitoring side effects. Researchers also looked at how many patients responded to the drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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17 people
The number who actually took part.
- Started
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Mar 2009
- Finished
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Apr 2017
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 -
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CH LENS
Lens, 62307, France
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Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
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Centre Hospitalier de la côte basque
Bayonne, 64109, France
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Ch Clermond Ferrand
Clermont-Ferrand, 63000, France
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Ch Nantes
Nantes, 44 093, France
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Chru Lille
Lille, 59037, France
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Groupe hospitalier Pitié Salpétrière
Paris, 75651, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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