Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

Study Overview
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Brief Summary
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This is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).

Detailed Description
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The primary endpoint was response rate according to International Uniform Criteria; secondary endpoints were: i) time to progression (TTP), progression free survival (PFS, and overall survival (OS); ii) percentage of eligible PPCL patients able to mobilize and collect peripheral blood stem cells after LD treatment; iii) percentage of eligible PPCL patients able to undergo autologous or allogeneic stem cells transplantation after LD treatment; iv) serious/severe adverse event (SAEs) rate.

Official Title
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A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia

Conditions
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Primary Plasma Cell Leukemia

Intervention / Treatment
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* Drug: Lenalidomide, dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed patients fulfilling the IMWG diagnostic criteria of PPCL Age > 18 years ECOG performance status of 0,1 or 2 Life expectancy of at least 12 weeks Exclusion Criteria: Myocardial infarction within 6 months prior to enrollment or uncontrolled angina Severe uncontrolled ventricular arrhythmias ECG evidence of acute ischemia or active conduction system abnormalities Female subjects either pregnant or breast-feeding Serious medical or psychiatric illness Total bilirubin greater than 2.0 mg/dL and/or SGOT or SGPT greater than two and a half times normal (unless due to primary malignancy) History of severe hepatic dysfunction Active infections or HIV positivity Uncontrolled insulin-dependent diabetes mellitus Uncompensated major thyroid or adrenal dysfunction Hemodialysis or peritoneal dialysis Renal dysfunction (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator) ECOG performance status of 3 (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lenalidomide, dexamethasone|Enrolled patients received lenalidomide at a dose of 25 mg/d for 21 days and oral dexamethasone at a dose of 40 mg on days 1, 8, 15, and 22 for each 28-day cycle. After 4 cycles, responding patients not eligible for SCT continued until 8 cycles of full-dose LD, if tolerated, followed by a maintenance dose of single agent lenalidomide equal to 10 mg/d on days 1-21 of each 28-day cycle. Patients responding after 4 cycles and eligible for SCT proceeded according to single Centre transplant policy. Patients not responding after 4 cycles or progressing during this treatment were considered off-study.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | IMWG criteria | 4 months | 
| Complete remission rate | IMWG | 4 months | 
| At least Very good partial remission rate | IMWG | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Median follow-up | 24 months | 
| Overall survival | Median follow-up | 24 months | 
| Percentage of patients able to perform stem cell transplantation | Number of eligible patients reaching stem cell transplantation procedure | 12 months | 
| Safety | Number of severe/serious adverse events | 4-8 months, according to protocol | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasma cell leukemia, Lenalidomide, Dexamethasone, Multiple myeloma, Bortezomib, Stem cell transplantation