Melphalan+Prednisolon With or Without Thalidomide in Previously Untreated Elderly Patients With Multiple Myeloma
Information source: Erkim Ilac A.S.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Thalidomide (Drug); Melphalan+Prednisolone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Cigdem Sahinbas YILMAZ Official(s) and/or principal investigator(s): Meral Beksac, Prof.Dr., Principal Investigator, Affiliation: Ankara University Rauf Haznedar, Prof.Dr., Principal Investigator, Affiliation: Gazi University
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
Clinical Details
Official title: Phase III Trial Comparing Treatment With Melphalan+Prednisolon (MP) With Melphalan+Prednisolon+Thalidomide (MPT) for Previously Untreated Elderly Patients With Multiple Myeloma
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: response rate
Secondary outcome: time to relapseoverall survival
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.
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Baskent University School of Medicine Education and Research Hospital, Hematology Department, Adana, 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, Ankara, Turkey
Akdeniz University School of Medicine , Hematology Department, Antalya 07070, Turkey
Uludag University School of Medicine, Hematology Department, Bursa, Turkey
Osmangazi University School of Medicine , Hematology Department, Eskisehir, Turkey
Marmara University School of Medicine, Hematology Department, Istanbul, Turkey
Additional Information
Starting date: March 2006
Last updated: August 14, 2013
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