Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Plasma Cell Leukemia |
Drug: Lenalidomide, dexamethasone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia |
- Overall response rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]IMWG criteria
- Complete remission rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]IMWG
- At least Very good partial remission rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]IMWG
- Progression free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]Median follow-up
- Overall survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]Median follow-up
- Percentage of patients able to perform stem cell transplantation [ Time Frame: 12 months ] [ Designated as safety issue: No ]Number of eligible patients reaching stem cell transplantation procedure
- Safety [ Time Frame: 4-8 months, according to protocol ] [ Designated as safety issue: Yes ]Number of severe/serious adverse events
| Enrollment: | 23 |
| Study Start Date: | March 2009 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
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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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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)
Contacts and Locations| Italy | |
| IRCCS - CROB Ethic Committee | |
| Rionero in Vulture, Pz, Italy, 85028 | |
| Principal Investigator: | Pellegrino Musto, MD | GIMEMA Multiple Myeloma Working Party |
More Information
No publications provided
| Responsible Party: | Pellegrino Musto, Onco-Hematology Department Director at IRCCS-CROB Rionero in Vulture, Italy, IRCCS Centro di Riferimento Oncologico della Basilicata |
| ClinicalTrials.gov Identifier: | NCT01553357 History of Changes |
| Other Study ID Numbers: | CROB0108/1 -- RV-PCL-PI-350, 2008-003246-28 |
| Study First Received: | March 3, 2012 |
| Last Updated: | March 13, 2012 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by IRCCS Centro di Riferimento Oncologico della Basilicata:
|
Plasma cell leukemia Lenalidomide Dexamethasone |
Multiple myeloma Bortezomib Stem cell transplantation |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Plasma Cell Neoplasms by Histologic Type Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Lenalidomide Thalidomide BB 1101 |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013