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Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma

NCT02114502 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-07-11

No results posted yet for this study

Summary

The goal of this clinical research study is to learn if carfilzomib and vorinostat combined with gemcitabine, busulfan, and melphalan with a stem cell transplant will help to control multiple myeloma (MM). Researchers also want to learn about the safety and effectiveness of this combination.

Conditions

Interventions

DRUG

Carfilzomib

27 mg/m2 by vein on Days -7 and -6, then on Days -2 and -1

DRUG

SAHA

1,000 mg by mouth on Days -8 to -3.

DRUG

Gemcitabine

Loading dose of 75 mg/m2 followed by continuous infusion of the remaining dose of 1875 mg/m2 by vein on Days -8 and -3.

DRUG

Busulfan

Test dose of 32 mg/m2 by vein on Day -10 if inpatient, on Day -12 if outpatient, then AUC of 4,000 microMol.min on Days -8 to -5.

DRUG

Melphalan

60 mg/m2 by vein on Days -3 and -2.

PROCEDURE

Stem Cell Transplant (SCT)

Stem cell transplant on Day 0.

DRUG

Palifermin

60 microgram/kg by vein on Days -12 to -10 and Days 0, +1 and +2.

DRUG

Dexamethasone

8 mg by vein twice a day from Day -9 PM to Day -2 PM.

DRUG

Caphosol

30 mL oral rinse four times a day from Day -9 until discharge.

DRUG

Glutamine

15 g four times a day, swished, gargled and spit on Day -9 until discharge.

DRUG

Pyridoxine

100 mg by vein or mouth three times a day from Day -1.

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
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-09-30

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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 NCT02114502 on ClinicalTrials.gov