Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma

Study Overview
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Brief Summary
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The protocol aims at reducing transplant toxicity and mortality in patients with multiple myeloma.

Detailed Description
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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.

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Procedure: Transplantation
* Procedure: Hematopoietic cell transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transplantation|nan|
|Procedure: Hematopoietic cell transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |