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Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden

NCT00651937 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-01-14

Study results available
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Summary

The goal of this clinical research study is to learn whether higher doses of stem cells can help to decrease the symptoms that occur after melphalan. Another goal of the study is to see how the dose of infused stem cells affects the levels of certain proteins in your blood. Researchers also want to learn how the dose of stem cells that you receive affects the quality of your life during the weeks after the transplant procedure.

Conditions

Interventions

DRUG

Melphalan

100 mg/m\^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion.

PROCEDURE

Stem Cell Infusion

Stem Cell Infusion is Day 0. Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10\^6 CD34/kg On Day 0 High Dose (Arm 2) = Stem cell dose of between 10-15 x 10\^6 CD34/kg On Day 0.

BEHAVIORAL

Questionnaires

Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.

DRUG

Granulocyte-colony stimulating factor (G-CSF)

5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days.

PROCEDURE

Apheresis

Collection of stem cells from blood collected either through CVC or from a vein in one arm.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Nina Shah, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States

Study Locations

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Entities

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 NCT00651937 on ClinicalTrials.gov