Multiple MyelomaPhase 3NCT00950768
Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients
A Phase 3 study testing Autologous transplantation in people with Multiple Myeloma and Diagnosis, run by Azienda Ospedaliera San Giovanni Battista.
Trial summary
In this study will be randomised before induction treatment either to receive two courses of melphalan 200 mg/m2 (MEL200) or two courses of melphalan 100 mg/m2 (MEL100). Informed consent will be obtained upon enrolment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma, Diagnosis
- What is being tested?
- Autologous transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Jun 2009
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of untreated Durie \& Salmon stage IIA-IIIB measurable multiple myeloma;
- age < 65 years.
Who cannot join
- prior treatment for myeloma;
- abnormal cardiac function, defined as systolic ejection fraction <50%;
- abnormal pulmonary spirometry test;
- serum bilirubins > 2.5 times normal and ALAT and/or ASAT > 2 times normal;
- seropositivity for HIV, HCV or HBV, active non-hematologic malignancies.
About this study
Official title: GISMM2001: Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients: a Prospective, Multi-center Phase III Study
In this study will be randomised before induction treatment either to receive two courses of melphalan 200 mg/m2 (MEL200) or two courses of melphalan 100 mg/m2 (MEL100). Informed consent will be obtained upon enrolment. Inclusion criteria included: diagnosis of untreated Durie e Salmon stage IIA-IIIB measurable multiple myeloma; age < 65 years. Exclusion criteria included: prior treatment for myeloma; abnormal cardiac function, defined as systolic ejection fraction <50%; abnormal pulmonary spirometry test; serum bilirubins > 2.5 times normal and ALAT and/or ASAT > 2 times normal; seropositivity for HIV, HCV or HBV, active non-hematologic malignancies.
Induction therapy, PBSC mobilization, and autografting Initial treatment plan included induction chemotherapy with 2 courses of vincristine, 1 mg/m2 on day 1, adriamycin, 50 mg/m2 on day 1, and dexamethasone, 40mg/day days 1-4, administered 28 days apart, followed by peripheral blood stem cell (PBSC) mobilisation and harvest after 1 or 2 cycles of cyclophosphamide, 4 g/m2, and G-CSF, 10 ug/kg given i.v. or subcutaneously. After at least one month from PBSC collection, autografting consisted of melphalan, 200 mg/m2 or melphalan, 100 mg/m2, on day -2, and cryopreserved PBSC infusion on day 0. Patients received G-CSF, 5 ug/kg, from days +3 until neutrophil count > 1000/ul were achieved.
Supportive care and toxicity grading Following autografting, all patients received standard prophylaxis against bacterial and fungal infections; herpes simplex and varicella-zoster virus reactivation; and Pneumocystis carinii. Cytomegalovirus CMV reactivation was monitored through levels of CMV antigenemia and/or serum CMV DNA levels and treated with ganciclovir or foscarnet as clinically indicated. Standard criteria (Common Toxicity Criteria version 3.0) were used for grading hematological and non-hematological toxicity.
- Conditions
- Multiple Myeloma, Diagnosis
- Being tested
- Autologous transplantation
- Keywords
- Myeloma, Melphalan, Autologous transplantation
- Medical subject headings
- Multiple Myeloma, Disease, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous transplantationProcedure or surgery
Tandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Mel100 | Active comparator | Not described Receives: Procedure: Autologous transplantation |
| Mel200 | Experimental | Not described Receives: Procedure: Autologous transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoints of the study were Overall Survival defined as the time from diagnosis until death from any cause; Progression Free Survival defined as the time from diagnosis until death from any cause or date of first relapse or progression.
Secondary outcomes (1)
Secondary endpoint was time to progression (TTP) defined as the time from the date of diagnosis to relapse or death from progression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startFeb 2002
- Primary completionMay 2009
- Study completionJun 2009
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
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
- Investigators
- Mario Boccadoro, MD, Principal investigator, Division of Hematology - University of Torino - A.O.U. San Giovanni Battista
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950768
- Sponsor's protocol ID
- GISMM2001
- Status last verified
- Jul 2009
- First submitted
- 31 Jul 2009
- Last updated
- 3 Aug 2009
- Results posted
- No
Publications
Palumbo A, Bringhen S, Bruno B, Falcone AP, Liberati AM, Grasso M, Ria R, Pisani F, Cangialosi C, Caravita T, Levi A, Meloni G, Nozza A, Pregno P, Gabbas A, Callea V, Rizzo M, Annino L, De Stefano V, Musto P, Baldi I, Cavallo F, Petrucci MT, Massaia M, Boccadoro M. Melphalan 200 mg/m(2) versus melphalan 100 mg/m(2) in newly diagnosed myeloma patients: a prospective, multicenter phase 3 study. Blood. 2010 Mar 11;115(10):1873-9. doi: 10.1182/blood-2009-09-241737. Epub 2009 Dec 1.
PubMed 19965659
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GISMM2001: Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients: a Prospective, Multi-center Phase III Study
- ClinicalTrials.gov ID
- NCT00950768
- Acronym / sponsor ID
- GISMM2001
- Conditions
- Multiple Myeloma, Diagnosis
- Keywords
- Myeloma, Melphalan, Autologous transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- Study start
- Feb 2002
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 3 Aug 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.
In this study will be randomised before induction treatment either to receive two courses of melphalan 200 mg/m2 (MEL200) or two courses of melphalan 100 mg/m2 (MEL100). Informed consent will be obtained upon enrolment. Inclusion criteria included: diagnosis of untreated Durie e Salmon stage IIA-IIIB measurable multiple myeloma; age < 65 years. Exclusion criteria included: prior treatment for myeloma; abnormal cardiac function, defined as systolic ejection fraction <50%; abnormal pulmonary spirometry test; serum bilirubins > 2.5 times normal and ALAT and/or ASAT > 2 times normal; seropositivity for HIV, HCV or HBV, active non-hematologic malignancies.
Induction therapy, PBSC mobilization, and autografting Initial treatment plan included induction chemotherapy with 2 courses of vincristine, 1 mg/m2 on day 1, adriamycin, 50 mg/m2 on day 1, and dexamethasone, 40mg/day days 1-4, administered 28 days apart, followed by peripheral blood stem cell (PBSC) mobilisation and harvest after 1 or 2 cycles of cyclophosphamide, 4 g/m2, and G-CSF, 10 ug/kg given i.v. or subcutaneously. After at least one month from PBSC collection, autografting consisted of melphalan, 200 mg/m2 or melphalan, 100 mg/m2, on day -2, and cryopreserved PBSC infusion on day 0. Patients received G-CSF, 5 ug/kg, from days +3 until neutrophil count > 1000/ul were achieved.
Supportive care and toxicity grading Following autografting, all patients received standard prophylaxis against bacterial and fungal infections; herpes simplex and varicella-zoster virus reactivation; and Pneumocystis carinii. Cytomegalovirus CMV reactivation was monitored through levels of CMV antigenemia and/or serum CMV DNA levels and treated with ganciclovir or foscarnet as clinically indicated. Standard criteria (Common Toxicity Criteria version 3.0) were used for grading hematological and non-hematological toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mel100 | Active comparator | Procedure: Autologous transplantation |
| Mel200 | Experimental | Procedure: Autologous transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of untreated Durie \& Salmon stage IIA-IIIB measurable multiple myeloma;
- age < 65 years.
Key exclusion criteria (5 listed)
- prior treatment for myeloma;
- abnormal cardiac function, defined as systolic ejection fraction <50%;
- abnormal pulmonary spirometry test;
- serum bilirubins > 2.5 times normal and ALAT and/or ASAT > 2 times normal;
- seropositivity for HIV, HCV or HBV, active non-hematologic malignancies.
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 |
|---|---|---|
| Autologous transplantationTandem autologous transplantation Melphalan 100 mg/m2 versus Melphalan 200 mg/m2 | Procedure or surgery | Mel100, Mel200 |
Primary outcome
Primary endpoints of the study were Overall Survival defined as the time from diagnosis until death from any cause; Progression Free Survival defined as the time from diagnosis until death from any cause or date of first relapse or progression.
1 secondary outcome
Secondary endpoint was time to progression (TTP) defined as the time from the date of diagnosis to relapse or death from progression.
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 3 Aug 2009.
- Derived from this study: PubMed 19965659Palumbo A, Bringhen S, Bruno B, Falcone AP, Liberati AM, Grasso M, Ria R, Pisani F, Cangialosi C, Caravita T, Levi A, Meloni G, Nozza A, Pregno P, Gabbas A, Callea V, Rizzo M, Annino L, De Stefano V, Musto P, Baldi I, Cavallo F, Petrucci MT, Massaia M, Boccadoro M. Melphalan 200 mg/m(2) versus melphalan 100 mg/m(2) in newly diagnosed myeloma patients: a prospective, multicenter phase 3 study. Blood. 2010 Mar 11;115(10):1873-9. doi: 10.1182/blood-2009-09-241737. Epub 2009 Dec 1.
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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.
Mario Boccadoro, MD principal investigator
Division of Hematology - University of Torino - A.O.U. San Giovanni Battista
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous transplantation in people with Multiple Myeloma and Diagnosis, run by Azienda Ospedaliera San Giovanni Battista.
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 2 inclusion and 5 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 3 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Primary endpoints of the study were Overall Survival defined as the time from diagnosis until death from any cause; Progression Free Survival defined as the time from diagnosis until death from any cause or date of first relapse or progression.. 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 NCT00950768, 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 3 Aug 2009.