Primary Plasma Cell Leukemia
Conditions
Keywords
Plasma cell leukemia, Lenalidomide, Dexamethasone, Multiple myeloma, Bortezomib, Stem cell transplantation
Brief summary
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
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.
Interventions
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.
Sponsors
Celgene Corporation
IRCCS Centro di Riferimento Oncologico della Basilicata
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate | 4 months | IMWG criteria |
| Complete remission rate | 4 months | IMWG |
| At least Very good partial remission rate | 4 months | IMWG |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 4-8 months, according to protocol | Number of severe/serious adverse events |
| Percentage of patients able to perform stem cell transplantation | 12 months | Number of eligible patients reaching stem cell transplantation procedure |
| Progression free survival | 24 months | Median follow-up |
| Overall survival | 24 months | Median follow-up |
Countries
Italy
Outcome results
None listed