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

NCT00934154 | Completed Phase 3 DMC

• 1 other identifier: TMSG-2005-001
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 9

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

Conditions

Multiple Myeloma

Keywords

multiple myeloma; thalidomide; melphalan; prednisolone; newly diagnosed; elderly; not eligible for transplantation

Outcome Measures

Primary Outcomes (1)

• response rate

  12 months

Secondary Outcomes (2)

• time to relapse

  18 months

• overall survival

  unlimited

Study Arms (2)

Thalidomide

EXPERIMENTAL

MPT

Drug: Thalidomide; Drug: Melphalan+Prednisolone

Control

ACTIVE COMPARATOR

MP

Drug: Melphalan+Prednisolone

Interventions

Thalidomide DRUG

100 mg/day continuously for 12 months

Thalidomide

Melphalan+Prednisolone DRUG

Melphalan 2 mg, Prednisolone 16 mg

Control; Thalidomide

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cigdem Sahinbas YILMAZ: lead
• Turkish Society of Hematology Myeloma Study Group: collaborator

Study Sites (9)

Baskent University School of Medicine Education and Research Hospital, Hematology Department

Adana, Turkey (Türkiye)

Location

Ankara Numune Education and Research Hospital,Hematology Department

Ankara, Turkey (Türkiye)

Location

Ankara University School of Medicine, Hematology Department

Ankara, Turkey (Türkiye)

Location

Gazi University School of Medicine, Hematology Department

Ankara, Turkey (Türkiye)

Location

Hacettepe University School of Medicine, Hematology Department

Ankara, Turkey (Türkiye)

Location

Akdeniz University School of Medicine , Hematology Department

Antalya, 07070, Turkey (Türkiye)

Location

Uludag University School of Medicine, Hematology Department

Bursa, Turkey (Türkiye)

Location

Osmangazi University School of Medicine , Hematology Department

Eskişehir, Turkey (Türkiye)

Location

Marmara University School of Medicine, Hematology Department

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Beksac M, Haznedar R, Firatli-Tuglular T, Ozdogu H, Aydogdu I, Konuk N, Sucak G, Kaygusuz I, Karakus S, Kaya E, Ali R, Gulbas Z, Ozet G, Goker H, Undar L. Addition of thalidomide to oral melphalan/prednisone in patients with multiple myeloma not eligible for transplantation: results of a randomized trial from the Turkish Myeloma Study Group. Eur J Haematol. 2011 Jan;86(1):16-22. doi: 10.1111/j.1600-0609.2010.01524.x. Epub 2010 Nov 22.

  PMID: 20942865 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Meral Beksac, Prof.Dr.

  Ankara University

  PRINCIPAL INVESTIGATOR

• Rauf Haznedar, Prof.Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medico Marketing Manager

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: March 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2012
• Last Updated: August 15, 2013

Record last verified: 2013-08

Locations

TU (9)