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S9922 Combination Chemo Plus Filgrastim With or Without Thalidomide in Refractory Multiple Myeloma

NCT00005834 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2015-03-06

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known if combination chemotherapy is more effective with or without thalidomide for multiple myeloma.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without thalidomide in treating patients who have refractory multiple myeloma.

Conditions

Interventions

BIOLOGICAL

filgrastim

Arms 1 and 2: 300 mcg (pts \</= 60 kg) or 480 mcg (pts \> 60 kg), SC beginning day 5

DRUG

cisplatin

Arms 1 and 2: 15 mg/m2/d continuous IV days 1-4

DRUG

cyclophosphamide

Arms 1 and 2: 400 mg/m2/d continuous IV days 1-4

DRUG

dexamethasone

Arms 1 and 2: 40 mg/d PO days 1-4

DRUG

etoposide

Arms 1 and 2: 40 mg/m2/d continuous IV days 1-4

DRUG

thalidomide

Arm 2: 800 mg/d (max dose) PO daily

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Mohamad A. Hussein, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-04-30
Primary Completion
2003-11-30
Completion
2007-11-30

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 NCT00005834 on ClinicalTrials.gov