Multiple MyelomaPhase 3NCT00934154
Melphalan+Prednisolon With or Without Thalidomide in Previously Untreated Elderly Patients With Multiple Myeloma
A Phase 3 study testing Thalidomide and Melphalan+Prednisolone in people with Multiple Myeloma, run by Cigdem Sahinbas YILMAZ at 9 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Thalidomide and Melphalan+Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 9 sitesTurkey (Türkiye)
- Study dates
- Mar 2006to Sep 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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".
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- 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).
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Turkey (Türkiye)9 sites
Baskent University School of Medicine Education and Research Hospital, Hematology Department
Adana
Ankara Numune Education and Research Hospital,Hematology Department
Ankara
Ankara University School of Medicine, Hematology Department
Ankara
Gazi University School of Medicine, Hematology Department
Ankara
Hacettepe University School of Medicine, Hematology Department
Ankara
Akdeniz University School of Medicine , Hematology Department
Antalya, 07070
Uludag University School of Medicine, Hematology Department
Bursa
Osmangazi University School of Medicine , Hematology Department
Eskişehir
Marmara University School of Medicine, Hematology Department
Istanbul
About this study
Official title: Phase III Trial Comparing Treatment With Melphalan+Prednisolon (MP) With Melphalan+Prednisolon+Thalidomide (MPT) for Previously Untreated Elderly Patients With Multiple Myeloma
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:
- Incidence and grade of any toxicity
- Level of maximum disease response
- Time to disease progression
- Time to death
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Thalidomide, Melphalan+Prednisolone
- Keywords
- multiple myeloma, thalidomide, melphalan, prednisolone, newly diagnosed, elderly, not eligible for transplantation
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
100 mg/day continuously for 12 months
Melphalan+PrednisoloneDrug
Melphalan 2 mg, Prednisolone 16 mg
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide | Experimental | MPT Receives: Drug: Thalidomide; Drug: Melphalan+Prednisolone |
| Control | Active comparator | MP Receives: Drug: Melphalan+Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: 12 months
Secondary outcomes (2)
time to relapse
Measured: 18 months
overall survival
Measured: unlimited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startMar 2006
- Primary completionSep 2009
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cigdem Sahinbas YILMAZ
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Turkish Society of Hematology Myeloma Study Group
- Responsible party
- Sponsor-investigator, Cigdem Sahinbas YILMAZ, Erkim Ilac A.S.
- Investigators
- Meral Beksac, Prof.Dr., Principal investigator, Ankara UniversityRauf Haznedar, Prof.Dr., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934154
- Sponsor's protocol ID
- TMSG-2005-001
- Status last verified
- Aug 2013
- First submitted
- 6 Jul 2009
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20942865
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial Comparing Treatment With Melphalan+Prednisolon (MP) With Melphalan+Prednisolon+Thalidomide (MPT) for Previously Untreated Elderly Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00934154
- Acronym / sponsor ID
- TMSG-2005-001
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma, thalidomide, melphalan, prednisolone, newly diagnosed, elderly, not eligible for transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Cigdem Sahinbas YILMAZIndustry (pharma, biotech, devices)
- Collaborators
- Turkish Society of Hematology Myeloma Study Group
- Study start
- Mar 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Incidence and grade of any toxicity
- Level of maximum disease response
- Time to disease progression
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thalidomide | Experimental | Drug: Thalidomide, Drug: Melphalan+PrednisoloneMPT |
| Control | Active comparator | Drug: Melphalan+PrednisoloneMP |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thalidomide100 mg/day continuously for 12 months | Drug | Thalidomide |
| Melphalan+PrednisoloneMelphalan 2 mg, Prednisolone 16 mg | Drug | Control, Thalidomide |
Primary outcome
response rate
Time frame: 12 months
2 secondary outcomes
time to relapse
Time frame: 18 months
overall survival
Time frame: unlimited
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
- Derived from this study: PubMed 20942865Beksac 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meral Beksac, Prof.Dr. principal investigator
Ankara University
Rauf Haznedar, Prof.Dr. principal investigator
Gazi University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thalidomide and Melphalan+Prednisolone in people with Multiple Myeloma, run by Cigdem Sahinbas YILMAZ at 9 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00934154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2013.