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


Phase 2
18 Years
N/A
Not Enrolling
Both
Primary Plasma Cell Leukemia

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Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Description:

IMWG criteria

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Pellegrino Musto, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

GIMEMA Multiple Myeloma Working Party

Authority:

Italy: The Italian Medicines Agency

Study ID:

CROB0108/1 -- RV-PCL-PI-350

NCT ID:

NCT01553357

Start Date:

March 2009

Completion Date:

September 2011

Related Keywords:

  • Primary Plasma Cell Leukemia
  • Plasma cell leukemia
  • Lenalidomide
  • Dexamethasone
  • Multiple myeloma
  • Bortezomib
  • Stem cell transplantation
  • Leukemia
  • Leukemia, Plasma Cell

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