Suspended

Myeloblative Therapy With Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and B-Cell Malignancies

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What is being tested

filgrastim

+ sargramostim

+ cyclophosphamide

BiologicalDrugProcedureRadiation
Who is being recruted

Amyloidosis+43

+ Blood Protein Disorders

+ Cardiovascular Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 1997
See protocol details

Summary

Principal SponsorMedical College of Wisconsin
Last updated: January 6, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1997

Actual date on which the first participant was enrolled.

OBJECTIVES: Determine the safety and efficacy of myeloablative therapy with autologous hematopoietic stem cell transplantation in patients with multiple myeloma and other B-cell malignancies. Determine the efficacy and pretransplantation prognostic factors associated with myeloablative therapy in these patients. Determine engraftment kinetics of granulocytes and platelets, as well as blood product transfusion requirements following hematopoietic stem cell transplantation. OUTLINE: Patients must have hematopoietic stem cell procurement completed prior to myeloablative therapy. Patients receive high dose chemotherapy with autologous hematopoietic stem cell transplantation and supportive care. Melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion. Peripheral blood stem cells and/or bone marrow is reinfused on day 0. Filgrastim (G-CSF) or sargramostim (GM-CSF) is administered beginning on day 1 posttransplantation and continuing until blood counts recover. Patients who are not candidates for tandem transplant may receive melphalan plus total body irradiation (TBI). Melphalan is administered IV on day -4. Total body irradiation is administered three times a day on days -3 and -2 and twice on day -1. At least 4 hours must elapse between each treatment. Hematopoietic stem cells are reinfused on day -1 upon completion of TBI or on day 0. If patient is ineligible for melphalan plus TBI, the alternative single high dose regimen of melphalan plus cyclophosphamide is administered. Melphalan, for these patients, is given in two equal doses on day -4 followed by two consecutive days of cyclophosphamide on days -3 and -2. Hematopoietic stem cells are reinfused on day 0. A second transplant may be considered, preferably between 3 and 6 months after the first transplant. The preferred regimen for the second transplant is melphalan alone or melphalan plus TBI as described above. The alternative regimens for the second dose therapy are melphalan alone or melphalan plus cyclophosphamide. For patients receiving melphalan alone, melphalan is administered in one dose on day -1 at least 12 hours before stem cell infusion. Hematopoietic stem cells are reinfused on day 0 for both alternative regimens. Patients are followed for response from treatment for a minimum of 4 weeks and then periodically for survival. PROJECTED ACCRUAL: A minimum of 10 patients will be accrued for this study.

NCT00003163
Principal SponsorMedical College of Wisconsin
Last updated: January 6, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AmyloidosisBlood Protein DisordersCardiovascular DiseasesChronic DiseaseDNA Virus InfectionsHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersMetabolic DiseasesNeoplasmsNeoplasms by Histologic TypeNutritional and Metabolic DiseasesParaproteinemiasPathologic ProcessesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVascular DiseasesVirus DiseasesLeukemia, B-CellLymphoma, B-CellEpstein-Barr Virus InfectionsHemostatic DisordersDisease AttributesProteostasis DeficienciesImmunoglobulin Light-chain AmyloidosisBurkitt LymphomaLymphomaLymphoma, FollicularLymphoma, Non-HodgkinWaldenstrom MacroglobulinemiaMultiple MyelomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-CellPrecursor Cell Lymphoblastic Leukemia-LymphomaNeoplasms, Plasma Cell

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma or other B-cell malignancy including non-Hodgkin's lymphoma, Waldenstrom's macroglobulinemia, or amyloidosis Non-Hodgkin's lymphoma with T-cell immunophenotypes included PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 2,000/mm^3 (unless due to disease) Platelet count at least 100,000/mm^3 (unless due to disease) Hepatic: Not specified Renal: Not specified Cardiovascular: LVEF at least 40% Pulmonary: DLCO or FVC and FEV1 at least 50% of predicted unless due to restriction from volume loss secondary to disease Other: HIV negative No overt infection or unexplained fever requiring broad spectrum antibiotics Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 2 weeks since prior biologic therapy Chemotherapy: At least 2 weeks since other prior chemotherapy and recovered Endocrine therapy: At least 2 weeks since prior endocrine therapy Concurrent steroids allowed Radiotherapy: Not specified Surgery: Not specified

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Medical College of Wisconsin

Milwaukee, United StatesOpen Medical College of Wisconsin in Google Maps
SuspendedOne Study Center