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

Phase 3
55 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

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

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.

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

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

- Other illnesses which would preclude chemotherapy administration or patient

- Any other serious medical or psychiatric illness which would prevent informed

- Peripheral neuropathy > NCI criteria grade 2.

- Pregnant or lactating women and patients of childbearing age who refuse to use

- History of hypersensitivity to thalidomide or any component of the medications.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Meral Beksac, Prof.Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ankara University


Turkey: Ministry of Health

Study ID:




Start Date:

March 2006

Completion Date:

September 2012

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • thalidomide
  • melphalan
  • prednisolone
  • newly diagnosed
  • elderly
  • not eligible for transplantation
  • Multiple Myeloma
  • Neoplasms, Plasma Cell