Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma

Phase 2

• Conditions: Multiple Myeloma

• Registration Number: NCT00327314
• Lead Sponsor: Azienda Ospedaliera San Giovanni Battista

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.

Study Timeline

• Study Start: 2002-12
• Study First Submitted: 2006-05-16
• Study First Submitted QC: 2006-05-16
• Study First Posted: 2006-05-18
• Study Completion: 2006-10
• Status Verified: 2006-12
• Last Update Submitted: 2006-12-27
• Last Update Posted: 2006-12-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Divisione Universitaria Ematologia Azienda Ospedaliera S G Battista; 🇮🇹 Torino, Italy