NCT00075621

Brief Summary

RATIONALE: Autologous stem cell transplantation may be effective treatment for primary systemic (AL) amyloidosis. PURPOSE: This phase II trial is studying how well tandem (two) autologous stem cell transplantation works in treating patients with primary systemic (AL) amyloidosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_2 multiple-myeloma

Timeline
Completed

Started Aug 2000

Longer than P75 for phase_2 multiple-myeloma

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

August 1, 2000

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
15.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2020

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

4.8 years

First QC Date

January 9, 2004

Last Update Submit

September 15, 2020

Conditions

Multiple Myeloma

Keywords

primary systemic amyloidosis

Outcome Measures

Primary Outcomes (1)

  • safety

    100 days, 6 months, and annual

Secondary Outcomes (1)

  • Efficacy

    one year

Study Arms (1)

tandem transplant

OTHER

Drug: filgrastim 16 mg/kg/day for 3 days prior to stem cell collection, through day before last collection Drug: melphalan 200 mg/kg over 2 days Procedure/Surgery: autologous peripheral blood stem cell transplantation autologous peripheral blood stem cell transplantation

Drug: filgrastimDrug: melphalanProcedure: autologous peripheral blood stem cell transplantation

Interventions

filgrastimDRUG

16 mg/kg/day for 3 days prior to stem cell collection, through day before last collection

tandem transplant
melphalanDRUG

200 mg/kg over 2 days

Also known as: alkeran
tandem transplant
autologous peripheral blood stem cell transplantationPROCEDURE

autologous peripheral blood stem cell transplantation

tandem transplant

Eligibility Criteria

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

You may qualify if:

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed AL amyloidosis, meeting 1 of the following criteria:
  • Plasma cell dyscrasia, evidenced by 1 of the following:
  • Monoclonal protein in the serum or urine by immunofixation electrophoresis
  • Plasmacytosis of the bone marrow with monoclonal staining for kappa or lambda light chain isotype
  • Macroglossia with at least 1 other site having biopsy proven amyloidosis and absence of a mutant transthyretin is ruled out
  • PATIENT CHARACTERISTICS:
  • Age
  • to 65
  • Performance status
  • SWOG 0-2
  • Life expectancy
  • At least 1 year
  • Hematopoietic
  • Not specified
  • +27 more criteria

You may not qualify if:

  • No senile, secondary, localized, dialysis-related, or familial amyloidosis
  • No overt multiple myeloma (e.g., greater than 30% bone marrow plasmacytosis, extensive \[more than 2\] lytic lesions, hypercalcemia)
  • Cardiovascular
  • No myocardial infarction within the past 6 months
  • No congestive heart failure
  • No arrhythmia refractory to therapy
  • No evidence of symptomatic transient ischemic attacks or strokes
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Multiple MyelomaImmunoglobulin Light-chain Amyloidosis

Interventions

FilgrastimMelphalan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino Acids

Study Officials

  • Vaishali Sanchorawala, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2004

First Posted

January 12, 2004

Study Start

August 1, 2000

Primary Completion

June 1, 2005

Study Completion

September 4, 2020

Last Updated

September 17, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)