NCT00327314

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_2 multiple-myeloma

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

December 28, 2006

Status Verified

December 1, 2006

First QC Date

May 16, 2006

Last Update Submit

December 27, 2006

Conditions

Multiple Myeloma

Interventions

TransplantationPROCEDURE
Hematopoietic cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Divisione Universitaria Ematologia Azienda Ospedaliera S G Battista

Torino, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

TransplantationStem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeutics

Study Officials

  • Benedetto Bruno, MD, PhD

    Divisione di Ematologia _ Azienda Ospedaliera S G Battista di Torino

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benedetto Bruno, MD, PhD

CONTACT

+39-011-6334419benedetto.bruno@unito.it

Luisa Giaccone, MD

CONTACT

+39-011-6334419luisa.giaccone@unito.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2006

First Posted

May 18, 2006

Study Start

December 1, 2002

Study Completion

October 1, 2006

Last Updated

December 28, 2006

Record last verified: 2006-12

Locations

IT(1)