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Non-Myeloablative Allogeneic Transplantation From Unrelated Donors in Multiple Myeloma

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00327314
Enrollment
100
Registered
2006-05-18
Start date
2002-12-31
Completion date
2006-10-31
Last updated
2006-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

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.

Interventions

PROCEDURETransplantation
PROCEDUREHematopoietic cell transplantation

Sponsors

Azienda Ospedaliera San Giovanni Battista
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Countries

Italy

Contacts

Primary ContactBenedetto Bruno, MD, PhD
benedetto.bruno@unito.it+39-011-6334419
Backup ContactLuisa Giaccone, MD
luisa.giaccone@unito.it+39-011-6334419

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026