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NCT00002548

Standard Dose Versus Myeloablative Therapy for Previously Untreated Symptomatic Multiple Myeloma, A Phase III Intergroup Study

Completed Phase 3 Last updated 5 March 2015
What this trial tests

Phase 3 trial testing recombinant interferon alfa in Multiple Myeloma in 899 participants. Completed in 1 November 2006.

Timeline
1 January 1994
Primary endpoint
1 October 2003
1 November 2006

Quick facts

Lead sponsorSWOG Cancer Research Network
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment899
Start date1 January 1994
Primary completion1 October 2003
Estimated completion1 November 2006
Sites34 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

SWOG Cancer Research Network

Who can join

Adults 18 to 70, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and radiation therapy and kill more cancer cells. It is not yet known which treatment regimen is more effective for multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of melphalan, total-body irradiation, and peripheral stem cell transplantation with that of combination chemotherapy in treating patients who have previously untreated multiple myeloma.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Extramedullary disease portends poor prognosis in multiple myeloma and is over-represented in high-risk disease even in the era of novel agents.
    Usmani SZ, Heuck C, Mitchell A, Szymonifka J, et al · · 2012 · cited 297× · PMID 22689675 · DOI 10.3324/haematol.2012.065698
  2. Modeling the relationship between progression-free survival and overall survival: the phase II/III trial.
    Redman MW, Goldman BH, LeBlanc M, Schott A, et al · · 2013 · cited 16× · PMID 23669424 · DOI 10.1158/1078-0432.ccr-12-2939

Verify or expand the search:

Other trials of recombinant interferon alfa

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

Other SWOG Cancer Research Network trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00002548.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing