Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma

Azienda Ospedaliera San Giovanni Battista

Status and phase: Unknown; Phase 2

Conditions: Multiple Myeloma

Treatments: Procedure: Transplantation; Procedure: Hematopoietic cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT00327314

MM 1641

Details and patient eligibility

About

The protocol aims at reducing transplant toxicity and mortality in patients with multiple myeloma.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)