- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00396383
Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation
Treatment With AMD3100 in Multiple Myeloma Patients to Mobilize Peripheral Blood Progenitor Cells For Collection and for Transplantation
Studieoversikt
Detaljert beskrivelse
This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if 240 µg/kg plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs) for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2*10^6 CD34+ cells/kg and the target is ≧4*10^6 CD34+ cells/kg. Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet (PLT) engraftment. Durability of engraftment will be assessed for a minimum of one year.
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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New York
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New York, New York, Forente stater, 10021
- Memorial Sloan-Kettering Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19107
- Thomas Jefferson University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diagnosis of multiple myeloma (MM)
- Eligible for autologous transplantation
- Patients in first or second partial remission (PR) or complete remission (CR)
- Patients who have received ≦2000 rads of prior radiation therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Recovered from all acute toxic effects of prior chemotherapy
- White blood cells (WBC) >3.0*10^9/l
- Absolute polymorphonuclear leucocyte (PMN) count >1.5*10^9/l
- Platelet (PLT) count > 150*10^9/l
- Serum creatinine ≦2.2 mg/dl
- Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 x upper limit of normal (ULN)
- Negative for HIV
- Signed informed consent
- Patients of childbearing potential agree to use an approved form of contraception
Exclusion Criteria:
- Patient received 2 or more alkylating agents, such as VBMCP (a combination of Vincristine, BCNU (Bis-Chloronitrosourea), Melphalan, Cyclophosphamide, and Prednisone)
- Patient received a total dose of ≧200 mg of prior melphalan
- A co-morbid condition which, in the view of the investigators, renders the patient at high risk from treatment complications
- Patient has failed previous collections or collection attempts
- A residual acute medical condition resulting from prior chemotherapy
- Brain metastases or carcinomatous meningitis
- Acute infection
- Fever (temperature >38 °C / 100.4 °F)
- Hypercalcemia (>1mg/dl above ULN)
- Positive pregnancy test in female patients
- Lactating females
- Patients of childbearing potential unwilling to implement adequate birth control
- Patients whose actual body weight exceeds 175% of their ideal body weight
- History of ventricular arrhythmias
- Patient received thalidomide within 10 days prior to receiving the first dose of plerixafor
- Patients who previously received experimental therapy within 4 weeks of enrolling in this protocol or who are currently enrolled in another experimental protocol during the mobilization phase
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Participants with Multiple Myeloma (MM)
Participants with MM who were eligible for autologous peripheral blood stem cell transplantation.
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Participants were given a 240 µg/kg dose of plerixafor by subcutaneous injection in the morning followed by apheresis 6 hours later.
Daily treatment with plerixafor followed by apheresis was administered for up to 4 consecutive days or until 4*10^6 CD34+ cells/kg body weight had been collected.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Who Achieved ≥4*10^6 CD34+ Cells/kg
Tidsramme: Day 1 up to day 4
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Number of participants achieving a target of ≥ 4*10^6 CD34+ cells/kg during apheresis for up to 4 consecutive days.
Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone).
Target was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.
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Day 1 up to day 4
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Participant Counts of Summarized Adverse Events (AE) During Treatment
Tidsramme: 1 month
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Participant counts of summarized adverse events (AEs) which occurred from the first dose of plerixafor up to the day prior to chemotherapy/ablative treatment.
Events were graded according to World Health Organization criteria: Mild (awareness of sign or symptom, but easily tolerated), Moderate (discomfort enough to cause interference with usual activity), Severe (incapacitating with inability to work or do usual activity).
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1 month
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Transplantations That Achieved Polymorphonuclear Leukocyte (PMN) Engraftment Grouped by Days to Engraftment
Tidsramme: Approximately 2 months
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Polymorphonuclear cell (PMN) engraftment was defined as a PMN count ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1*10^9/L for 1 day.
Days to engraftment corresponded to the first day that the criteria were met after transplantation.
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Approximately 2 months
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Number of Transplantations That Achieved Platelet (PLT) Engraftment Grouped by Days to Engraftment
Tidsramme: Approximately 2 months
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Platelet (PLT) engraftment was defined as a PLT count of ≥ 20*10^9/L for 7 days without transfusion.
Days to engraftment corresponded to the first day that the criteria were met after transplantation.
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Approximately 2 months
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Number of Participants With a Durable Graft at 12 Months Post Transplantation
Tidsramme: Approximately month 13
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Graft durability was assessed by the Investigator based on complete blood count (CBC) and differential analyses at 12 months post transplantation.
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Approximately month 13
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Flomenberg N, Comenzo R, Badel K, Calandra G. Single agent AMD3100 mobilization of peripheral blood progenitor cells for autologous transplantation in patients with multiple myeloma (MM) [abstract]. Blood. Nov 16 2006;108(11 Pt 1):965a.
- Flomenberg N, Comenzo RL, Badel K, Calandra G. Plerixafor (Mozobil) alone to mobilize hematopoietic stem cells from multiple myeloma patients for autologous transplantation. Biol Blood Marrow Transplant. 2010 May;16(5):695-700. doi: 10.1016/j.bbmt.2009.12.538. Epub 2010 Jan 11.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Hematologiske sykdommer
- Hemoragiske lidelser
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Multippelt myelom
- Neoplasmer, plasmacelle
- Anti-infeksjonsmidler
- Antivirale midler
- Anti-HIV-midler
- Antiretrovirale midler
- Plerixafor
Andre studie-ID-numre
- AMD3100-2108
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Kliniske studier på Multippelt myelom
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National Cancer Institute (NCI)Aktiv, ikke rekrutterendeMyelom-multippel | Myelom, plasmacelleForente stater
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National Cancer Institute (NCI)FullførtMyelom-multippel | Myelom, plasmacelleForente stater
-
National Cancer Institute (NCI)FullførtMyelom-multippel | Myelom, plasmacelleForente stater
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National Cancer Institute (NCI)AvsluttetMyelom, multippel | Myelom-multippelForente stater
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Tel-Aviv Sourasky Medical CenterFullførtPlasmacellemyelom | Myelom-multippel | Myelom multippel | Myelom, plasmacelleIsrael
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National Cancer Institute (NCI)Georgetown University; Hackensack Meridian HealthAvsluttetMyelom-multippel | Myelom, plasmacelle | MyelomatoseForente stater
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University of ChicagoNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeStage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelomForente stater, Canada
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Sidney Kimmel Cancer Center at Thomas Jefferson...FullførtStage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelomForente stater
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University of Southern CaliforniaNational Cancer Institute (NCI); Celgene CorporationAvsluttetStage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelomForente stater
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TilbaketrukketStage I Myelom | Stadium II multippelt myelom | Stadium III multippelt myelom
Kliniske studier på plerixafor
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National Heart, Lung, and Blood Institute (NHLBI)Fullført
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Stephen CoubanGenzyme, a Sanofi CompanyFullførtOndartet lymfom, stamcelletypeCanada
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Kyowa Kirin Co., Ltd.FullførtMultippelt myelom og ondartet lymfomJapan
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University Hospital, Clermont-FerrandFullførtBarnekreft, solid svulstFrankrike
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Genzyme, a Sanofi CompanyFullførtNedsatt nyrefunksjonForente stater
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University of WashingtonFullført
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SanofiFullførtAutolog hematopoetisk stamcelletransplantasjonKina
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National Institute of Allergy and Infectious Diseases...Lombardi Comprehensive Cancer CenterAvsluttetKreftForente stater
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Seattle Children's HospitalChildren's Healthcare of Atlanta; Pediatric Oncology Experimental Therapeutics...FullførtAML | Akutt leukemi av tvetydig avstamning | ALLE | Tilbakefallende/Refraktær AML | Tilbakefall/Ildfast ALT | Sekundær AML/MDSForente stater, Canada