Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Transplantation Type: Procedure
Name: Hematopoietic cell transplantation Type: Procedure
Overall Status
Recruiting
Summary
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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:

- 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

- 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
Location
Divisione Universitaria Ematologia Azienda Ospedaliera S G Battista
Torino, Italy
Status: Recruiting
Start Date
December 2002
Completion Date
October 2006
Sponsors
Azienda Ospedaliera San Giovanni Battista
Source
Azienda Ospedaliera San Giovanni Battista
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page