Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

March 13, 2012 updated by: Pellegrino Musto, IRCCS Centro di Riferimento Oncologico della Basilicata

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Pz
      • Rionero in Vulture, Pz, Italy, 85028
        • IRCCS - CROB Ethic Committee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Centro di Riferimento Oncologico della Basilicata

Collaborators

Celgene Corporation

Investigators

  • Principal Investigator: Pellegrino Musto, MD, GIMEMA Multiple Myeloma Working Party

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

March 3, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (ESTIMATE)

March 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

March 14, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CROB0108/1 -- RV-PCL-PI-350
  • 2008-003246-28 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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