Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma

Multiple Myeloma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00327314
• Other study ID #: MM 1641
• Status: Recruiting
• Phase: Phase 2
• First received: May 16, 2006
• Last updated: December 27, 2006
• Start date: December 2002
• Est. completion date: October 2006

Study information

• Verified date: December 2006
• Source: Azienda Ospedaliera San Giovanni Battista
• Contact: Benedetto Bruno, MD, PhD
• Phone: +39-011-6334419
• Email: benedetto.bruno[@]unito.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Procedure:
• Transplantation

• Hematopoietic cell transplantation

Locations

Country	Name	City	State
Italy	Divisione Universitaria Ematologia Azienda Ospedaliera S G Battista	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Giovanni Battista

Country where clinical trial is conducted

Italy,