NCT00007995

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with multiple myeloma or primary systemic amyloidosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 1999

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

July 1, 1999

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 4, 2013

Status Verified

July 1, 2007

Enrollment Period

8.3 years

First QC Date

January 6, 2001

Last Update Submit

February 1, 2013

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomaprimary systemic amyloidosis

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival at 2 years (patients with responsive disease)

Secondary Outcomes (3)

  • Duration of hematologic toxicity

  • Time to an absolute neutrophil count

  • Platelet independence

Interventions

filgrastimBIOLOGICAL
recombinant interferon alfaBIOLOGICAL
sargramostimBIOLOGICAL
busulfanDRUG
cyclophosphamideDRUG
melphalanDRUG
autologous bone marrow transplantationPROCEDURE
bone marrow ablation with stem cell supportPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed multiple myeloma OR * Primary systemic amyloidosis resulting in significant organ dysfunction and decreased quality of life * Complete or partial response after standard chemotherapy * Primary refractory or relapsed multiple myeloma after first-line treatment with standard chemotherapy * Ineligible for higher priority national or institutional clinical studies PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2 times normal Renal: * Creatinine less than 2.5 mg/dL or on stable hemodialysis Cardiovascular: * LVEF at least 45% Pulmonary: * DLCO at least 60% of predicted OR * Approval by pulmonologist Other: * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Concurrent participation in gene therapy trials allowed Chemotherapy: * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy: * No concurrent steroids as antiemetics during chemotherapy * No concurrent anticancer hormonal therapy Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent barbiturates or acetaminophen during chemotherapy * Concurrent participation in supportive care trials allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma CellImmunoglobulin Light-chain Amyloidosis

Interventions

FilgrastimInterferon-alphasargramostimBusulfanCyclophosphamideMelphalanPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms 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 FactorsInterferon Type IInterferonsButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Charles S. Hesdorffer, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

July 1, 1999

Primary Completion

November 1, 2007

Study Completion

May 1, 2008

Last Updated

February 4, 2013

Record last verified: 2007-07

Locations

US(1)