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High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma

NCT00586014 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2014-07-08

No results posted yet for this study

Summary

The purpose of this phase II study is to assess the toxicity and efficacy of sequentially administered high dose chemotherapy followed by autologous stem cell rescue in the treatment of multiple myeloma. Prior studies have shown that dose-intensified melphalan can produce higher response rates and complete remission in some patients. Over the past several years, multiple phase II studies utilizing high dose chemotherapy or high dose chemo-radiotherapy with autologous marrow or peripheral blood stem cell rescue have demonstrated improved response rates and survival rates compared to historical controls. Recently a prospective randomized trial has demonstrated improved response rates, response duration and overall survival utilizing high dose therapy with autologous bone marrow support compared to standard chemotherapy. The primary cause of failure is relapse and it is unclear how many, if any, patients are cured by this approach. Based on observations of efficacy in Hodgkin's Disease, Non-Hodgkin's Lymphoma, and breast cancer, an approach utilizing sequential high dose chemotherapy in multiple myeloma was developed. This protocol tests the sequential regimen in multiple myeloma patients who have responded to a standard dose chemotherapy regimen prior to enrollment.

Conditions

Interventions

PROCEDURE

High-Dose Sequential Chemotherapy followed by ASCT

Patient will receive Cyclophosphamide(4 g/m2 over 2 hours) and blood progenitor cell collection (day -49). G-CSF (10 mcg/kg/d) will be administered SQ. A six hour leukapheresis will be performed,cells will undergo CD34+ cell selection, patients will receive high dose VP-16 (Etopophos)(day -28)(2 g/m2 over 4 hours)and G-CSF (5 mcg/kg/d) will be administered SQ two days following VP-16. The an IV of sulfamethoxazole-trimethoprim 1 ampule BID for 5 days (Day -5). BCNU 500 mg/m2 IV over 2 hours (Day -4). Melphalan (Day -2) will be administered IV (200 mg/m2 over 20 minutes). The frozen peripheral blood mononuclear cells will be transfused on Day 0. Day +1: G-CSF 5 mcg/kg/d SQ for 3 days.

Sponsors & Collaborators

Principal Investigators

  • Nelson Chao, MD · Duke Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-05-31
Primary Completion
2006-01-31
Completion
2008-02-29

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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 NCT00586014 on ClinicalTrials.gov