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Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01553357
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : March 14, 2012
Celgene Corporation
Information provided by (Responsible Party):
Pellegrino Musto, IRCCS Centro di Riferimento Oncologico della Basilicata

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).

Condition or disease Intervention/treatment Phase
Primary Plasma Cell Leukemia Drug: Lenalidomide, dexamethasone Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia
Study Start Date : March 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : September 2011

Intervention Details:
  • 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.

    Other Name: Revlimid

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 4 months ]
    IMWG criteria

  2. Complete remission rate [ Time Frame: 4 months ]

  3. At least Very good partial remission rate [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 24 months ]
    Median follow-up

  2. Overall survival [ Time Frame: 24 months ]
    Median follow-up

  3. Percentage of patients able to perform stem cell transplantation [ Time Frame: 12 months ]
    Number of eligible patients reaching stem cell transplantation procedure

  4. Safety [ Time Frame: 4-8 months, according to protocol ]
    Number of severe/serious adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01553357

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IRCCS - CROB Ethic Committee
Rionero in Vulture, Pz, Italy, 85028
Sponsors and Collaborators
IRCCS Centro di Riferimento Oncologico della Basilicata
Celgene Corporation
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Principal Investigator: Pellegrino Musto, MD GIMEMA Multiple Myeloma Working Party
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Responsible Party: Pellegrino Musto, Onco-Hematology Department Director at IRCCS-CROB Rionero in Vulture, Italy, IRCCS Centro di Riferimento Oncologico della Basilicata Identifier: NCT01553357    
Other Study ID Numbers: CROB0108/1 -- RV-PCL-PI-350
2008-003246-28 ( EudraCT Number )
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: March 2012
Keywords provided by Pellegrino Musto, IRCCS Centro di Riferimento Oncologico della Basilicata:
Plasma cell leukemia
Multiple myeloma
Stem cell transplantation
Additional relevant MeSH terms:
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Leukemia, Plasma Cell
Neoplasms by Histologic Type
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors