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High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma

NCT01237951 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-05-05

Study results available
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Summary

The goal of this clinical research study is to learn if the combination of gemcitabine, busulfan, and melphalan, when given before a stem cell transplant, can help to control refractory myeloma. The safety of this study treatment will also be studied.

Conditions

Interventions

DRUG

Palifermin

60 micrograms/kg infused as an IVP (by vein) over 15-30 seconds Days -12 to -10 and Days 0 to +2 as an outpatient. 60 micrograms/kg by vein on Days -13 to -11 and on Days 0, +1 and +2 as in inpatient.

DRUG

Dexamethasone

8 mg IV twice a day by vein over 15 minutes Days -9 through -2 as an outpatient or inpatient.

DRUG

Gemcitabine

1875 mg/m\^2 IV (75 mg/ m2 bolus followed by 1800 mg/m\^2 over 3 hours) on Day -8 and Day -3 as an outpatient or inpatient.

DRUG

Busulfan

32 mg/m2 test dose with PKs as outpatient before Day -12, or as an inpatient on Day -10. Busulfan AUC 4,000 by vein on Days -8 to -5 as an outpatient or inpatient.

DRUG

Melphalan

60 mg/m\^2 IV on Days -3 and -2 over 30 minutes on both days as an outpatient or inpatient.

PROCEDURE

Stem Cell Transplant

On Day 0, stem cells returned to body by vein over 30-60 minutes.

DRUG

G-CSF

5 mcg/kg/day subcutaneously beginning on Day +5 and continuing until neutrophil recovery is documented.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Yago Nieto, MD, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-08
Primary Completion
2017-09-20
Completion
2017-09-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01237951 on ClinicalTrials.gov