NCT00186407

Brief Summary

To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 1998

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 1998

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

9.8 years

First QC Date

September 13, 2005

Last Update Submit

September 10, 2010

Conditions

AmyloidosisBlood and Marrow Transplant (BMT)

Outcome Measures

Primary Outcomes (1)

  • To evaluate the role of high dose therapy and autologous hematopoietic cell transplant for amyloidosis

Interventions

high dose chemo then auto hematopoietic cell transplantPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Age \< 75 years.
  • \. Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.
  • \. Patients who have undergone bone marrow transplantation previously will not be eligible.
  • \. Patients must have a Karnofsky performance status greater than 70%.
  • \. Patients must have a serum creatinine less than 2 mg/dl or creatinine clearance greater than 30 ml/min, bilirubin less than 2 mg/dl, transaminases less than two times normal, left ventricular ejection fraction \>45% on echocardiography, cardiac index \> 1.8 liters/min/m\^2 and pulmonary function tests demonstrating FEV1 and DLCO \> 60%.
  • \. Patients must be HIV negative.
  • \. Pregnant or lactating women will not be eligible to participate.
  • \. Patients must provide signed informed consent.
  • \. Patients with multiple myeloma and amyloid are eligible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sally Arai

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

April 1, 1998

Primary Completion

February 1, 2008

Study Completion

February 1, 2010

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations

US(1)