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Melphalan+Prednisolon With or Without Thalidomide in Previously Untreated Elderly Patients With Multiple Myeloma

NCT00934154 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2013-08-15

No results posted yet for this study

Summary

This is a multi-centre Phase III randomized controlled study of patients with multiple myeloma (MM). Eligible patients who are not candidates for transplantation will be randomized to receive eight courses of Melphalan/Prednisolone with or without Thalidomide treatment. Thalidomide will be initiated at the dose of 100 mg/day and maintained at 100 mg/day. The patients will be assessed for any responses at the end of 2nd, 4th, 6th and 8th cycles of treatment. The toxicities will be assessed at monthly intervals. Patients will be assessed for the:

1. Incidence and grade of any toxicity
2. Level of maximum disease response
3. Time to disease progression
4. Time to death

Conditions

Interventions

DRUG

Thalidomide

100 mg/day continuously for 12 months

DRUG

Melphalan+Prednisolone

Melphalan 2 mg, Prednisolone 16 mg

Sponsors & Collaborators

  • Turkish Society of Hematology Myeloma Study Group

    collaborator UNKNOWN

  • Cigdem Sahinbas YILMAZ

    lead INDUSTRY

Principal Investigators

  • Meral Beksac, Prof.Dr. · Ankara University

  • Rauf Haznedar, Prof.Dr. · Gazi University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2009-09-30
Completion
2012-09-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

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 NCT00934154 on ClinicalTrials.gov