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Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma

NCT01731886 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-02-05

Study results available
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Summary

The study is being done to compare the combination of lenalidomide and dexamethasone followed by autologous peripheral blood stem cell transplant (PBSCT) and lenalidomide and dexamethasone without PBSCT in patients with untreated multiple myeloma. This comparison will include how the subjects respond to each study treatment combination, and what side effects are caused by each combination.

Conditions

Interventions

PROCEDURE

Autologous peripheral blood stem cell transplant

Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.

DRUG

Lenalidomide

Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.

DRUG

Dexamethasone

Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.

PROCEDURE

Stem cell collection

Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is \>2500 x 109 cells/liter; platelet count is \>20 x 103/mm3.

DRUG

Melphalan

Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.

DRUG

G-CSF

Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.

DRUG

Cyclophosphamide

Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.

DRUG

Mesna

Mesna will be provided with the cyclophosphamide.

Sponsors & Collaborators

Principal Investigators

  • Suzanne Lentzsch, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2017-04-11
Completion
2017-04-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01731886 on ClinicalTrials.gov