Multiple MyelomaPhase 2NCT00702247
Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)
A Phase 2 study testing Hematopoietic Stem Cell Transplantation in people with Multiple Myeloma, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
Trial summary
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Hematopoietic Stem Cell Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteItaly
- Study dates
- Jul 1999to 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Durie-Salmon stage IIA-IIIB multiple myeloma
- Age > 18 and ≤ 65 years
- Previously untreated myeloma
- Presence of a sibling (potential donor)
- Bilirubins < twice normal;ALAT and ASAT < four times normal
- Left ventricular ejection fraction > 40%
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- Creatinine clearances > 40 mL/min
- Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) > 40% and/or need for continuous oxygen supplementation
- Karnofsky performance status > 60%
- Patients must give written informed consent
Who cannot join
- Age > 65 years
- Previously treated myeloma
- Absence of a sibling (genetic randomisation cannot be applied)
- Karnofsky performance status score < 60%
- HIV-infection
- Pregnancy
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- Refusal to use contraceptive techniques during and for 12 months following treatment
- Patients unable to give written informed consent
- PS. Informed consent is obtained from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Università di Torino - Azienda Ospedaliera S.Giovanni Battista
Torino, 10126
Benedetto Bruno, MD, PhD, +39-011-6334419, benedetto.bruno@unito.it
Mario Boccadoro, +39-011-6336728, mario.boccadoro@unito.it
About this study
Official title: Allogeneic Stem Cell Transplantation for Multiple Myeloma: a Two Step Approach to Reduce Toxicity Involving High-Dose Melphalan and Autologous Stem Cell Transplant Followed by PBSC Allografting After Low-Dose TBI
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years
- Conditions
- Multiple Myeloma
- Being tested
- Hematopoietic Stem Cell Transplantation
- Keywords
- Multiple Myeloma - Nonmyeloablative transplantation - Autologous Transplant - Graft versus myeloma, Newly diagnosed multiple myeloma, Tandem Auto-Allo Transplant, Overall survival, Event free survival, Disease response
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematopoietic Stem Cell TransplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Hematopoietic Stem Cell Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: yearly
Secondary outcomes (1)
event free survival
Measured: yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startJul 1999
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
- Investigators
- Bruno Benedetto, MD, PhD, Principal investigator, University of Torino - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702247
- Sponsor's protocol ID
- 00019702/3174
- Status last verified
- Jun 2008
- First submitted
- 19 Jun 2008
- Last updated
- 20 Jun 2008
- Results posted
- No
Publications
Bruno B, Rotta M, Patriarca F, Mattei D, Allione B, Carnevale-Schianca F, Sorasio R, Rambaldi A, Casini M, Parma M, Bavaro P, Onida F, Busca A, Castagna L, Benedetti E, Iori AP, Giaccone L, Palumbo A, Corradini P, Fanin R, Maloney D, Storb R, Baldi I, Ricardi U, Boccadoro M. Nonmyeloablative allografting for newly diagnosed multiple myeloma: the experience of the Gruppo Italiano Trapianti di Midollo. Blood. 2009 Apr 2;113(14):3375-82. doi: 10.1182/blood-2008-07-167379. Epub 2008 Dec 8.
PubMed 19064724
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Stem Cell Transplantation for Multiple Myeloma: a Two Step Approach to Reduce Toxicity Involving High-Dose Melphalan and Autologous Stem Cell Transplant Followed by PBSC Allografting After Low-Dose TBI
- ClinicalTrials.gov ID
- NCT00702247
- Acronym / sponsor ID
- 00019702/3174
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma - Nonmyeloablative transplantation - Autologous Transplant - Graft versus myeloma, Newly diagnosed multiple myeloma, Tandem Auto-Allo Transplant, Overall survival, Event free survival, Disease response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- Study start
- Jul 1999
- First posted
- 20 Jun 2008 (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.
To evaluate toxicity profile and efficacy of a tandem autologous-nonmyeloablative transplant approach in newly diagnose myeloma patients younger than 65 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Hematopoietic Stem Cell Transplantation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Durie-Salmon stage IIA-IIIB multiple myeloma
- Age > 18 and ≤ 65 years
- Previously untreated myeloma
- Presence of a sibling (potential donor)
- Bilirubins < twice normal;ALAT and ASAT < four times normal
Key exclusion criteria (9 listed)
- Age > 65 years
- Previously treated myeloma
- Absence of a sibling (genetic randomisation cannot be applied)
- Karnofsky performance status score < 60%
- HIV-infection
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 |
|---|---|---|
| Hematopoietic Stem Cell Transplantation | Procedure or surgery | 1 |
Primary outcome
overall survival
Time frame: yearly
1 secondary outcome
event free survival
Time frame: yearly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2008.
- Derived from this study: PubMed 19064724Bruno B, Rotta M, Patriarca F, Mattei D, Allione B, Carnevale-Schianca F, Sorasio R, Rambaldi A, Casini M, Parma M, Bavaro P, Onida F, Busca A, Castagna L, Benedetti E, Iori AP, Giaccone L, Palumbo A, Corradini P, Fanin R, Maloney D, Storb R, Baldi I, Ricardi U, Boccadoro M. Nonmyeloablative allografting for newly diagnosed multiple myeloma: the experience of the Gruppo Italiano Trapianti di Midollo. Blood. 2009 Apr 2;113(14):3375-82. doi: 10.1182/blood-2008-07-167379. Epub 2008 Dec 8.
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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.
Bruno Benedetto, MD, PhD principal investigator
University of Torino - Italy
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 Hematopoietic Stem Cell Transplantation in people with Multiple Myeloma, run by Azienda Ospedaliera San Giovanni Battista 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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Jun 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benedetto Bruno, MD, PhD (+39-011-6334419, benedetto.bruno@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: yearly). 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 NCT00702247, 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 20 Jun 2008.