NCT00046852

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 autologous peripheral stem cell transplantation and immunotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Randomized phase I/II trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation followed by immunotherapy in treating patients who have multiple myeloma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 2001

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

2.9 years

First QC Date

October 3, 2002

Last Update Submit

October 31, 2019

Conditions

InfectionMultiple Myeloma and Plasma Cell Neoplasm

Keywords

infectionrefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myeloma

Interventions

filgrastimBIOLOGICAL
pneumococcal polyvalent vaccineBIOLOGICAL
therapeutic autologous lymphocytesBIOLOGICAL
therapeutic tumor infiltrating lymphocytesBIOLOGICAL
carmustineDRUG
cyclophosphamideDRUG
melphalanDRUG
bone marrow ablation with stem cell supportPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of multiple myeloma requiring systemic treatment * No obvious myelodysplastic changes in the marrow PATIENT CHARACTERISTICS: Age * 18 to 80 Performance status * ECOG 0-2 (ECOG 3-4 allowed if based solely on bone pain) Life expectancy * Not specified Hematopoietic * Not specified Hepatic * No chronic active hepatitis * No liver cirrhosis Renal * Creatinine no greater than 3.0 mg/dL * No dialysis Cardiovascular * LVEF at least 45% unless no evidence of untreated clinically significant functional impairment Pulmonary * FEV\_1 and FVC at least 50% of predicted * Total lung capacity at least 50% of predicted * DLCO at least 50% of predicted * Mild to moderate pulmonary impairment (lower DLCO) allowed but patients would not receive study carmustine * Patients unable to complete pulmonary function test due to bone pain or fracture must have high-resolution CT scan of the chest and arterial partial pressure of oxygen greater than 70 Other * No active infections requiring IV antibiotics * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Prior pulse dexamethasone (1-2 courses) allowed * Concurrent pulse dexamethasone allowed during mobilization therapy Radiotherapy * Not specified Surgery * Not specified

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

Sponsors & Collaborators

Study Sites (2)

Marlene and Stewart Greenebaum Cancer Center, University of Maryland

Baltimore, Maryland, 21201, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

InfectionsMultiple MyelomaNeoplasms, Plasma Cell

Interventions

FilgrastimPneumococcal VaccinesCarmustineCyclophosphamideMelphalanPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsStreptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Aaron P. Rapoport, MD

    University of Maryland Greenebaum Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2002

First Posted

January 27, 2003

Study Start

December 1, 2001

Primary Completion

November 1, 2004

Study Completion

February 1, 2008

Last Updated

November 4, 2019

Record last verified: 2019-10

Locations

US(2)