Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim (G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect at least 6 million stem cells in two or less apheresis sessions.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
-
-
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85006
- City of Hope Samaritan Bone Marrow Transplant Program
-
-
Arkansas
-
Little Rock, Arkansas, Forenede Stater, 72205
- Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
-
-
California
-
Duarte, California, Forenede Stater, 91010
- City of Hope National Medical Center
-
Los Angeles, California, Forenede Stater, 90048
- Cedars-Sinai
-
Los Angeles, California, Forenede Stater, 90095
- University of California
-
-
Colorado
-
Denver, Colorado, Forenede Stater, 80218
- Rocky Mountain Cancer Center
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06520
- Yale University School of Medicine
-
-
Florida
-
Gainesville, Florida, Forenede Stater, 32611
- University of Florida
-
Tampa, Florida, Forenede Stater, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30322
- Emory University
-
-
Illinois
-
Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
-
-
Indiana
-
Beech Grove, Indiana, Forenede Stater, 46107
- Indiana Blood and Marrow Transplantation Center
-
-
Iowa
-
Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hosptials and Clinics
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55455
- Fairview-University Medical Center, University of Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64111
- Kansas City Cancer Center
-
Saint Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine, Division of Bone Marrow Transplantation and Leukemia
-
-
New Jersey
-
Hackensack, New Jersey, Forenede Stater, 07601
- The Cancer Center at Hackensack University Medical Center
-
-
New York
-
Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
-
New York, New York, Forenede Stater, 10011
- St. Vincent's Comprehensive Cancer Center
-
New York, New York, Forenede Stater, 10065
- Memorial Sloan Kettering
-
New York, New York, Forenede Stater, 10032
- New York Hospital
-
Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center
-
-
North Carolina
-
Durham, North Carolina, Forenede Stater, 27705
- Duke University Medical Center
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Forenede Stater, 44195
- Cleveland Clinic Foundation
-
Columbus, Ohio, Forenede Stater, 43210
- Ohio State University
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97239
- Oregon Health & Science University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- Hospital of the University of Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- The University of Texas MD Anderson Cancer Center
-
Lackland AFB, Texas, Forenede Stater, 78236
- Wilford Hall Medical Center
-
San Antonio, Texas, Forenede Stater, 78229
- Texas Transplant Institute
-
San Antonio, Texas, Forenede Stater, 78229
- University of Texas Health Science Center
-
-
Utah
-
Salt Lake City, Utah, Forenede Stater, 84132
- Utah Blood and Marrow Transplant Program, University of Utah
-
-
Virginia
-
Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98109
- Fred Hutchinson Cancer Research Center
-
-
-
-
-
Heidelberg, Tyskland, 69120
- Universitätsklinikum Heidelberg,
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Diagnosis of multiple myeloma in first or second complete or partial remission
- >= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade were not considered prior chemotherapy for the purpose of this study)
- Recovered from all acute toxic effects of prior chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- White Blood Cell count (WBC) > 2.5*10^9/L
- Absolute polymorphonuclear leukocytes (PMN) count > 1.5*10^9/L
- Platelet (PLT) > 100*10^9/L
- Serum creatinine <=2.2 mg/dL
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
- Negative for HIV
Exclusion Criteria):
- Failed previous stem cell collection
- Previous stem cell transplantation
- Brain metastases or myelomatous meningitis
- Radiation to ≥ 50% of the pelvis
- Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
- Received bone-seeking radionuclides (e.g. holmium)
- A residual acute medical condition resulting from prior chemotherapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: G-CSF plus plerixafor
|
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection.
On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection.
On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx.
10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration).
Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
Andre navne:
|
|
Placebo komparator: G-CSF plus placebo
|
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection.
On the evening of Day 4, participants received placebo, administered by SC injection.
On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx.
10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration).
Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
Tidsramme: up to Day 6
|
Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 2 or fewer days of apheresis.
Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period.
Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.
|
up to Day 6
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Antal deltagere med uønskede hændelser
Tidsramme: op til dag 38
|
Antal deltagere med behandlingsfremkomne bivirkninger (AE'er).
Tidsrammen for behandlingsfremkaldte AE'er er defineret som dag 1 (start af G-CSF-mobilisering) til dagen før start af kemoterapi (ca. 38 dage senere).
AE'er blev rapporteret uanset forholdet til undersøgelsesbehandlingen.
Investigatoren bedømte hver AE ved hjælp af World Health Organization (WHO) Adverse Event Grading Scale.
Bivirkninger af grad 3 blev betragtet som alvorlige og grad 4 blev betragtet som livstruende.
|
op til dag 38
|
|
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
Tidsramme: up to Day 8
|
Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 4 or fewer days of apheresis.
Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period.
Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
|
up to Day 8
|
|
Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
Tidsramme: up to Day 8
|
Proportion of participants achieving a target of ≥ 2*10^6 CD34+ cells/kg in 4 or fewer days of apheresis.
Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period.
Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
|
up to Day 8
|
|
Median Number of Days to ≥6*10^6 CD34+ Cells/kg
Tidsramme: up to Day 8
|
The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6*10^6 CD34+ cells/kg) for transplantation.
|
up to Day 8
|
|
Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
Tidsramme: Up to Month 13
|
The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint.
Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day.
Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.
|
Up to Month 13
|
|
Median Number of Days to Platelet (PLT) Engraftment
Tidsramme: Up to Month 13
|
The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint.
Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days.
Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.
|
Up to Month 13
|
|
Graft Durability at 100 Days Post Transplantation
Tidsramme: approximately Day 138
|
The proportion of participants maintaining a durable graft at 100 days post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
|
approximately Day 138
|
|
Graft Durability at 6 Months Post Transplantation
Tidsramme: approximately Month 7
|
The proportion of participants maintaining a durable graft at 6 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
|
approximately Month 7
|
|
Graft Durability at 12 Months Post Transplantation
Tidsramme: approximately Month 13
|
The proportion of participants maintaining a durable graft at 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
|
approximately Month 13
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Hæmatologiske sygdomme
- Hæmoragiske lidelser
- Hæmostatiske lidelser
- Paraproteinæmier
- Blodproteinforstyrrelser
- Myelomatose
- Neoplasmer, Plasmacelle
- Lægemidlers fysiologiske virkninger
- Anti-infektionsmidler
- Antivirale midler
- Anti-HIV-midler
- Anti-retrovirale midler
- Immunologiske faktorer
- Adjuvanser, immunologiske
- Lenograstim
- Plerixafor
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- AMD3100-3102
- 2005-003599-39 (EudraCT nummer)
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 .
Kliniske forsøg med Myelomatose
-
NCT07622862Ikke rekrutterer endnuMyelomprogression | Multiple myeloma -ildfast
-
NCT07456605RekrutteringMyelom i tilbagefald | Multiple myeloma -ildfast
-
NCT07521982Ikke rekrutterer endnu
-
NCT07477912RekrutteringAnti-BCMA CAR-T-celleterapi for voksne med tilbagevendende eller refraktær myelomatose (MSTH-CAR001)Multiple myeloma -ildfast
-
NCT07210047Tilmelding efter invitationMultiple myeloma -ildfast
-
NCT07421856Ikke rekrutterer endnuMyelom i tilbagefald | Multiple myeloma -ildfast
-
NCT07045909RekrutteringDe novo multiple myeloma | Anitocabtagene Autoleucel
-
NCT07096778RekrutteringMyelom i tilbagefald | Multiple myeloma -ildfast
-
NCT07150468AfsluttetAkut leukæmi, myelodysplastisk syndrom, myeloproliferative neoplasmer, lymfom, multiple myeloma
Kliniske forsøg med Granulocyte colony-stimulating factor plus plerixafor
-
NCT00984178UkendtReperfunderet akut myokardieinfarkt
-
NCT07362810RekrutteringHæmatopoetisk stamcelletransplantation | Mobilisering af hæmatopoietiske stamceller (HSC) til perifert blod (PB) | Hæmato-onkologiske patienter
-
NCT00514215AfsluttetNyrekræft | Lungekræft | Uspecificeret fast tumor hos voksne, protokolspecifik | Metastatisk kræft
-
NCT05088356Aktiv, ikke rekrutterendeMyelodysplastiske syndromer | Myeloproliferative lidelser | Akut leukæmi | Kronisk myelogen leukæmi | Allogen hæmatopoietisk celletransplantation (HCT) | Avancerede hæmatologiske maligniteter