Status:
COMPLETED
Melphalan+Prednisolon With or Without Thalidomide in Previously Untreated Elderly Patients With Multiple Myeloma
Lead Sponsor:
Cigdem Sahinbas YILMAZ
Collaborating Sponsors:
Turkish Society of Hematology Myeloma Study Group
Conditions:
Multiple Myeloma
Eligibility:
All Genders
55+ years
Phase:
PHASE3
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 co...
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00934154
Start Date
March 1 2006
End Date
September 1 2012
Last Update
August 15 2013
Active Locations (9)
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1
Baskent University School of Medicine Education and Research Hospital, Hematology Department
Adana, Turkey (Türkiye)
2
Ankara Numune Education and Research Hospital,Hematology Department
Ankara, Turkey (Türkiye)
3
Ankara University School of Medicine, Hematology Department
Ankara, Turkey (Türkiye)
4
Gazi University School of Medicine, Hematology Department
Ankara, Turkey (Türkiye)