Multiple MyelomaPhase 2NCT01274403
A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With Multiple Myeloma
A Phase 2 study testing Melphalan, Prednisone and Thalidomide in people with Multiple Myeloma, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
Trial summary
The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Melphalan, Prednisone and Thalidomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- newly diagnosed of multiple myeloma.
- Age > 65 years
- ECOG <= 3
- Written informed consent given at the time of randomization
- Patients with age <= 65 but not eligible for high dose treatment with stem cells support
Who cannot join
- ECOG > 3
- current neoplasm..
- contraindications to use thalidomide
- peripheral neurophaty
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.
- Conditions
- Multiple Myeloma
- Being tested
- Melphalan, Prednisone and Thalidomide
- Keywords
- Multiple Myeloma, Elderly patients
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melphalan, Prednisone and ThalidomideDrug
| Study group | Role | What they receive |
|---|---|---|
| Melphalan, prednisone plus Thalidomide | Experimental | Not described Receives: Drug: Melphalan, Prednisone and Thalidomide |
| Melphalan and Prednisone | Active comparator | Not described Receives: Drug: Melphalan, Prednisone and Thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy
To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment
Measured: from 8 to 12 months
To assess the toxicity
To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0
Measured: From 1 to 12 months
Secondary outcomes (2)
To evaluate the Overall Survival (OS) in the 2 arms of treatment
OS was defined as the time from the date of first treatment after diagnosis of multiple myeloma to the date of last follow up examination or the date of death from any cause
Measured: From 1 to 60 months
To evaluate the Duration of Remission (DR) in the 2 arms of treatment
DR was defined from the date of Complete Remission, Partial Remission, Minimal response after the completion of MPT or MP cycles to the date of disease progression or the date of last follow up examination
Measured: From 8 to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Studio Linfomi
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274403
- Sponsor's protocol ID
- MM03
- Status last verified
- Dec 2010
- First submitted
- 28 Dec 2010
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study With Oral Melphalan + Prednisone (MP) Versus Melphalan, + Prednisone + Thalidomide (MPT) for Newly Diagnosesd Elderly Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01274403
- Acronym / sponsor ID
- MM03
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Elderly patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Gruppo Italiano Studio LinfomiUniversity, hospital or other
- First posted
- 11 Jan 2011 (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.
The aim of the study is to compare efficacy and toxicity of melphalan and prednisone versus meplhalan, prednisone and Thalidomide in elderly patients with multiple myeloma or patients with multiple myeloma but not eligible for high dose treatment with stem cells support.
Study design
- Allocation
- Randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melphalan, prednisone plus Thalidomide | Experimental | Drug: Melphalan, Prednisone and Thalidomide |
| Melphalan and Prednisone | Active comparator | Drug: Melphalan, Prednisone and Thalidomide |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- newly diagnosed of multiple myeloma.
- Age > 65 years
- ECOG <= 3
- Written informed consent given at the time of randomization
- Patients with age <= 65 but not eligible for high dose treatment with stem cells support
Key exclusion criteria (4 listed)
- ECOG > 3
- current neoplasm..
- contraindications to use thalidomide
- peripheral neurophaty
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 |
|---|---|---|
| Melphalan, Prednisone and Thalidomide | Drug | Melphalan and Prednisone, Melphalan, prednisone plus Thalidomide |
Primary outcome
To assess the efficacy
Time frame: from 8 to 12 months
To compare the percentage of response in term of complete response, partial response, minimal and stable disease in the 2 arms o treatment
To assess the toxicity
Time frame: From 1 to 12 months
To evaluate the toxicity in the 2 arms of treatment utilized the common terminology criteria for adverse events (CTCAE) version 3.0
2 secondary outcomes
To evaluate the Overall Survival (OS) in the 2 arms of treatment
Time frame: From 1 to 60 months
To evaluate the Duration of Remission (DR) in the 2 arms of treatment
Time frame: From 8 to 60 months
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 11 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melphalan, Prednisone and Thalidomide in people with Multiple Myeloma, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
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 5 inclusion and 4 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 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To assess the efficacy (time frame: from 8 to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2011.