Back to results

Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

Primary Purpose

Primary Plasma Cell Leukemia

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Lenalidomide, dexamethasone

About this trial

This is an interventional treatment trial for Primary Plasma Cell Leukemia focused on measuring Plasma cell leukemia, Lenalidomide, Dexamethasone, Multiple myeloma, Bortezomib, Stem cell transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

IRCCS - CROB Ethic Committee

Outcomes

Primary Outcome Measures

Overall response rate

IMWG criteria

Complete remission rate

IMWG

At least Very good partial remission rate

IMWG

Secondary Outcome Measures

Progression free survival

Median follow-up

Overall survival

Median follow-up

Percentage of patients able to perform stem cell transplantation

Number of eligible patients reaching stem cell transplantation procedure

Safety

Number of severe/serious adverse events

Full Information

NCT ID

NCT01553357

First Posted

March 3, 2012

Last Updated

March 13, 2012

Sponsor

IRCCS Centro di Riferimento Oncologico della Basilicata

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01553357

Brief Title

Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

IRCCS Centro di Riferimento Oncologico della Basilicata

Collaborators

Celgene Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Plasma Cell Leukemia

Keywords

Plasma cell leukemia, Lenalidomide, Dexamethasone, Multiple myeloma, Bortezomib, Stem cell transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Lenalidomide, dexamethasone

Other Intervention Name(s)

Revlimid

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall response rate

Description

IMWG criteria

Time Frame

4 months

Title

Complete remission rate

Description

IMWG

Time Frame

4 months

Title

At least Very good partial remission rate

Description

IMWG

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Progression free survival

Description

Median follow-up

Time Frame

24 months

Title

Overall survival

Description

Median follow-up

Time Frame

24 months

Title

Percentage of patients able to perform stem cell transplantation

Description

Number of eligible patients reaching stem cell transplantation procedure

Time Frame

12 months

Title

Safety

Description

Number of severe/serious adverse events

Time Frame

4-8 months, according to protocol

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pellegrino Musto, MD

Organizational Affiliation

GIMEMA Multiple Myeloma Working Party

Official's Role

Principal Investigator

Facility Information:

Facility Name

IRCCS - CROB Ethic Committee

City

Rionero in Vulture

State/Province

ZIP/Postal Code

85028

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia

We'll reach out to this number within 24 hrs