Multiple MyelomaPhase 2NCT00327314
Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma
A Phase 2 study testing Transplantation and Hematopoietic cell transplantation in people with Multiple Myeloma, run by Azienda Ospedaliera San Giovanni Battista at 1 site in Italy.
Trial summary
The protocol aims at reducing transplant toxicity and mortality in patients with multiple myeloma. 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?
- Transplantation and Hematopoietic cell transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2002to Oct 2006
- 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
- Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
- Age > 18 and ≤ 65 years at the start of the donor search
- Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant
- Capacity to give informed consent
Who cannot join
- Age > 65 years
- Karnofsky performance status score < 60%
- Progressive disease or stable disease for less than three months
- Central nervous system involvement
- Left ventricular ejection fraction < 35% or symptomatic heart failure
- Poorly controlled hypertension
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- Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) < 40% and/or need for continuous oxygen supplementation
- Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or SGPT greater than four times the upper limits of normal
- HIV positive patients
- Pregnancy
- Refusal to use contraceptive techniques during and for 12 months following treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Divisione Universitaria Ematologia Azienda Ospedaliera S G Battista
Torino, 10126
Benedetto Bruno, MD, PhD
Luisa Giaccone, MD
About this study
The protocol aims at reducing transplant toxicity and mortality in patients with multiple myeloma.
Read the detailed description
Primary end points are engraftment and non-relapse mortality. Secondary end points are disease response, overall survival, progression and event free survivals. Patient eligibility criteria.
Inclusion criteria included:
- Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
- Age > 18 and ≤ 65 years at the start of the donor search
- Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant
- Capacity to give informed consent
Exclusion criteria included:
- Age > 65 years
- Karnofsky performance status score < 60%
- Progressive disease or stable disease for less than three months
- Central nervous system (CNS) involvement
- Left ventricular ejection fraction < 35% or symptomatic heart failure
- Poorly controlled hypertension
- Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) < 40% and/or need for continuous oxygen supplementation
- Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or SGPT greater than four times the upper limits of normal
- HIV positive patients
- Pregnancy
- Refusal to use contraceptive techniques during and for 12 months following treatment
Informed consent is obtained during study registration from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.
- Conditions
- Multiple Myeloma
- Being tested
- Transplantation, Hematopoietic cell 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.
TransplantationProcedure or surgery
Hematopoietic cell transplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startDec 2002
- Study completionOct 2006
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Giovanni Battista
- Sponsor type
- University, hospital or other
- Investigators
- Benedetto Bruno, MD, PhD, Principal investigator, Divisione di Ematologia _ Azienda Ospedaliera S G Battista di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327314
- Sponsor's protocol ID
- MM 1641
- Status last verified
- Dec 2006
- First submitted
- 16 May 2006
- Last updated
- 28 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00327314
- Acronym / sponsor ID
- MM 1641
- Conditions
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Azienda Ospedaliera San Giovanni BattistaUniversity, hospital or other
- Study start
- Dec 2002
- Study completion
- Oct 2006
- First posted
- 18 May 2006 (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 protocol aims at reducing transplant toxicity and mortality in patients with multiple myeloma.
Detailed description
Primary end points are engraftment and non-relapse mortality. Secondary end points are disease response, overall survival, progression and event free survivals. Patient eligibility criteria.
Inclusion criteria included:
- Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
- Age > 18 and ≤ 65 years at the start of the donor search
- Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant
- Capacity to give informed consent
Exclusion criteria included:
- Age > 65 years
- Karnofsky performance status score < 60%
- Progressive disease or stable disease for less than three months
- Central nervous system (CNS) involvement
- Left ventricular ejection fraction < 35% or symptomatic heart failure
- Poorly controlled hypertension
- Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) < 40% and/or need for continuous oxygen supplementation
- Abnormal liver disease with a serum bilirubin greater than twice normal or SGOT and/or SGPT greater than four times the upper limits of normal
- HIV positive patients
- Pregnancy
- Refusal to use contraceptive techniques during and for 12 months following treatment
Informed consent is obtained during study registration from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Durie-Salmon stage IIA-IIIB multiple myeloma
- Age > 18 and ≤ 65 years at the start of the donor search
- Presence of concurrent co-morbidities precluding myeloablative conditioning or refusal to undergo a conventional allogeneic transplant
- Capacity to give informed consent
Key exclusion criteria (11 listed)
- Age > 65 years
- Karnofsky performance status score < 60%
- Progressive disease or stable disease for less than three months
- Central nervous system involvement
- Left ventricular ejection fraction < 35% or symptomatic heart failure
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 |
|---|---|---|
| Transplantation | Procedure or surgery | – |
| Hematopoietic cell transplantation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2006.
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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.
Benedetto Bruno, MD, PhD principal investigator
Divisione di Ematologia _ Azienda Ospedaliera S G Battista di Torino
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 Transplantation and Hematopoietic 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 4 inclusion and 11 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 28 Dec 2006. 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.
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 28 Dec 2006.