Trial record 1 of 11 for:    "Plasma cell leukemia"
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Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Pellegrino Musto, IRCCS Centro di Riferimento Oncologico della Basilicata
ClinicalTrials.gov Identifier:
NCT01553357
First received: March 3, 2012
Last updated: March 13, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by IRCCS Centro di Riferimento Oncologico della Basilicata:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553357

Locations
Italy
IRCCS - CROB Ethic Committee
Rionero in Vulture, Pz, Italy, 85028
Sponsors and Collaborators
IRCCS Centro di Riferimento Oncologico della Basilicata
Celgene Corporation
Investigators
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, Plasma Cell
Leukemia
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Multiple Myeloma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Growth Inhibitors
Growth Substances

ClinicalTrials.gov processed this record on October 23, 2014