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

August 14, 2013 updated by: Cigdem Sahinbas YILMAZ

Phase III Trial Comparing Treatment With Melphalan+Prednisolon (MP) With Melphalan+Prednisolon+Thalidomide (MPT) for Previously Untreated Elderly Patients With Multiple Myeloma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial will include patients who are not candidates for transplantation and above the age of 55. Treatment cycles will include (MP)melphalan (9 mg /sq.m/day d1-4), prednisolone (60 mg/sq.m/d,d1-4) every six weeks for maximum 8 cycles. Patients will be randomised to (MPT) Thalidomide (1:1) 100 mg/day continuously. Cross-over to MPT is allowed if insufficient response is obtained in the MP arm. response will be evaluated every other cycle. At the end of 12 months of treatment patients will be followed until progress and death. Second line treatment is not defined.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey
        • Baskent University School of Medicine Education and Research Hospital, Hematology Department
      • Ankara, Turkey
        • Ankara Numune Education and Research Hospital,Hematology Department
      • Ankara, Turkey
        • Ankara University School of Medicine, Hematology Department
      • Ankara, Turkey
        • Gazi University School of Medicine, Hematology Department
      • Ankara, Turkey
        • Hacettepe University School of Medicine, Hematology Department
      • Antalya, Turkey, 07070
        • Akdeniz University School of Medicine , Hematology Department
      • Bursa, Turkey
        • Uludag University School of Medicine, Hematology Department
      • Eskisehir, Turkey
        • Osmangazi University School of Medicine , Hematology Department
      • Istanbul, Turkey
        • Marmara University School of Medicine, Hematology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age above 55 years old.
  • Diagnosis of MM (Appendix A) and staging (Appendix B), previously untreated.
  • Performance status ECOG, 0, 1, or 2 (Appendix C).
  • Written informed consent to the study medications and bone marrow biopsy at diagnosis, 12 weeks and 6 months and/or off-study assessment.

  • Women who are pregnant or lactating at the time of diagnosis are ineligible. All women of child-bearing potential must have a negative pregnancy test within 24hrs of commencing the thalidomide and must take adequate precautions to prevent pregnancy and should not plan on conceiving children during the treatment program:

    • Adequate precautions are defined as "at least one highly effective method i.e., IUD, hormonal (birth control pills, injections, or implants), tubal ligation, partner's vasectomy AND one additional effective method i.e., latex condom, diaphragm, cervical cap".
    • Women becoming pregnant on protocol will be removed immediately from protocol.
    • Male patients (including patients having had a vasectomy) must use barrier contraception during and for four weeks after completing the thalidomide.
  • Patients remain eligible in the presence of abnormal renal function and/or liver function at time of enrollment.
  • Absence of severe dementia, able to take medication at home.
  • Absence of systemic disorders (gastrointestinal, pulmonary, cardiac and neurological).

Exclusion Criteria:

  • Asymptomatic myeloma or solitary plasmacytoma of bone or extramedullary plasmacytoma (without evidence of myeloma).
  • Previous or concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas.
  • Previous treatment for myeloma, except minimal local radiotherapy to relieve bone pain.
  • Other illnesses which would preclude chemotherapy administration or patient compliance.
  • Any other serious medical or psychiatric illness which would prevent informed consent.
  • Peripheral neuropathy > NCI criteria grade 2.
  • Pregnant or lactating women and patients of childbearing age who refuse to use contraception.
  • History of hypersensitivity to thalidomide or any component of the medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thalidomide
MPT
Drug: Thalidomide
100 mg/day continuously for 12 months
Drug: Melphalan+Prednisolone
Melphalan 2 mg, Prednisolone 16 mg
Active Comparator: Control
MP
Drug: Melphalan+Prednisolone
Melphalan 2 mg, Prednisolone 16 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
time to relapse
Time Frame: 18 months
18 months
overall survival
Time Frame: unlimited
unlimited

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cigdem Sahinbas YILMAZ

Collaborators

Turkish Society of Hematology Myeloma Study Group

Investigators

  • Principal Investigator: Meral Beksac, Prof.Dr., Ankara University
  • Principal Investigator: Rauf Haznedar, Prof.Dr., Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 6, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMSG-2005-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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