Clinical trial NCT00327314: Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Azienda Ospedaliera San Giovanni Battista
Sponsor class: OTHER
First posted: 2006-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Divisione Universitaria Ematologia Azienda Ospedaliera S G Battista
Study officials:
affiliation: Divisione di Ematologia _ Azienda Ospedaliera S G Battista di Torino
name: Benedetto Bruno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: