Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma
NCT ID: NCT00327314
Last Updated: 2006-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2002-12-31
2006-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transplantation
Hematopoietic cell transplantation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Azienda Ospedaliera San Giovanni Battista
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Benedetto Bruno, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Divisione di Ematologia _ Azienda Ospedaliera S G Battista di Torino
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Divisione Universitaria Ematologia Azienda Ospedaliera S G Battista
Torino, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MM 1641
Identifier Type: -
Identifier Source: org_study_id