NCT01553357

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2012

Completed
Last Updated

March 14, 2012

Status Verified

March 1, 2012

Enrollment Period

2.4 years

First QC Date

March 3, 2012

Last Update Submit

March 13, 2012

Conditions

Primary Plasma Cell Leukemia

Keywords

Plasma cell leukemiaLenalidomideDexamethasoneMultiple myelomaBortezomibStem cell transplantation

Outcome Measures

Primary Outcomes (3)

  • Overall response rate

    IMWG criteria

    4 months

  • Complete remission rate

    IMWG

    4 months

  • At least Very good partial remission rate

    IMWG

    4 months

Secondary Outcomes (4)

  • Progression free survival

    24 months

  • Overall survival

    24 months

  • Percentage of patients able to perform stem cell transplantation

    12 months

  • Safety

    4-8 months, according to protocol

Interventions

Lenalidomide, dexamethasoneDRUG

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.

Also known as: Revlimid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS - CROB Ethic Committee

Rionero in Vulture, Pz, 85028, Italy

Location

MeSH Terms

Conditions

Leukemia, Plasma CellMultiple Myeloma

Interventions

LenalidomideDexamethasone

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsNeoplasms, Plasma CellHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Pellegrino Musto, MD

    GIMEMA Multiple Myeloma Working Party

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Onco-Hematology Department Director at IRCCS-CROB Rionero in Vulture, Italy

Study Record Dates

First Submitted

March 3, 2012

First Posted

March 14, 2012

Study Start

March 1, 2009

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

March 14, 2012

Record last verified: 2012-03

Locations

IT(1)