Clinical trial NCT00934154: Melphalan+Prednisolon With or Without Thalidomide in Previously Untreated Elderly Patients With Multiple Myeloma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: multiple myeloma
thalidomide
melphalan
prednisolone
newly diagnosed
elderly
not eligible for transplantation
Lead sponsor: Erkim Ilac A.S.
Sponsor class: INDUSTRY
Collaborators: name: Turkish Society of Hematology Myeloma Study Group
First posted: 2009-07-08
Enrollment: 122
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: response rate
timeFrame: 12 months
Secondary outcomes:
measure: time to relapse
timeFrame: 18 months
measure: overall survival
timeFrame: unlimited
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University School of Medicine Education and Research Hospital, Hematology Department
city: Ankara
country: Turkey
facility: Ankara Numune Education and Research Hospital,Hematology Department
city: Ankara
country: Turkey
facility: Ankara University School of Medicine, Hematology Department
city: Ankara
country: Turkey
facility: Gazi University School of Medicine, Hematology Department
city: Ankara
country: Turkey
facility: Hacettepe University School of Medicine, Hematology Department
city: Antalya
country: Turkey
facility: Akdeniz University School of Medicine , Hematology Department
city: Bursa
country: Turkey
facility: Uludag University School of Medicine, Hematology Department
city: Eskisehir
country: Turkey
facility: Osmangazi University School of Medicine , Hematology Department
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine, Hematology Department
Study officials:
affiliation: Ankara University
name: Meral Beksac, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Rauf Haznedar, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.