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Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

NCT00005792 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2019-11-08

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have multiple myeloma.

Conditions

Interventions

DRUG

etoposide phosphate

Etoposide phosphate 1363 mg/m\^2/day IV over 4 hours (total dose 2726 mg/m\^2, or 2400 mg/m\^2 etoposide equivalents), beginning 24 hours after the completion of the last infusion of topotecan Days -4, -3

DRUG

melphalan

Melphalan 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2), followed immediately by topotecan. Days -7, -6, -5

DRUG

topotecan

Topotecan 3.3 mg/m\^2/day (starting total dose = 10 mg/m\^2 for level 2) IV over 30 minutes. No topotecan will be administered on the first dose level Days -7, -6, -5

PROCEDURE

Autologous Stem Cell Rescue

reinfusion of stem cells, Day 0

Sponsors & Collaborators

  • SmithKline Beecham

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Daniel M. Sullivan, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-06-02
Primary Completion
2006-07-01
Completion
2018-11-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00005792 on ClinicalTrials.gov