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Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers

3. januar 2014 opdateret af: Medical College of Wisconsin

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

RATIONALE: Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation in treating patients who have multiple myeloma or other B-cell cancers.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

10

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: David H. Vesole, MD, PhD, Medical College of Wisconsin

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 1997

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

17. april 2003

Først opslået (Skøn)

18. april 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. januar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. januar 2014

Sidst verificeret

1. oktober 2002

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CDR0000065959
  • MCW-96110
  • MCW-HRRC-29196
  • NCI-V97-1368

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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