- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00847639
Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma (07-REV)
Evaluation of Lenalidomide as Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for High-risk Multiple Myeloma
This is a multi-institution, non-randomized, open label, Phase IIa prospective trial to evaluate the safety and tolerability of maintenance lenalidomide after allogeneic hematopoietic stem cell transplantation (HCT).
Lenalidomide maintenance therapy will start between day 60 and 90 after allogeneic HCT at a starting dose of 10mg PO once daily. Dose escalation and de-escalation will be performed depending on tolerability of lenalidomide. Dose range is 5mg every other day to 5 - 25 mg given daily on days 1-21 of a 28-day cycle for 12 cycles maximum or maximum of 12 months from first dose of study drug.
Patients will be followed until 28 days from completing the 12th planned cycle of lenalidomide maintenance or 12 months from first dose of study drug, which ever comes first, (14 to 15 months after receiving the allograft) or discontinuation of study drug.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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California
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Duarte, California, Forente stater, 91010
- City of Hope National Medical Center
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Florida
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Tampa, Florida, Forente stater, 33612
- H. Lee Moffitt Cancer Center & Research Institute
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- University of Minnesota Medical Center
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Hackensack University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- University of Pennsylvania Hospital Center
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Texas
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Houston, Texas, Forente stater, 77030
- The University of Texas, M.D. Anderson Cancer Center
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Washington
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Seattle, Washington, Forente stater, 98195
- Fred Hutchinson Cancer Research Center
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- Medical College of Wisconsin
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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:
- One prior allograft from an 8/8 or 7/8 allele matched related or unrelated donor, received 60 to 90 days prior to initiation of lenalidomide
- Meet the diagnostic criteria of symptomatic myeloma at anytime prior to allogeneic HCT
- Have high-risk multiple myeloma
- Received ≤ three (3) prior lines of therapy. Prior therapies may include: combination chemotherapy, monotherapy, lenalidomide and autologous HCT. Localized radiation therapy does not count as a single line of therapy. Previous progression on lenalidomide does not exclude participation in the study.
- Received a reduced intensity conditioning regimen
- Received or are receiving a GVHD prophylaxis regimen of a calcineurin inhibitor in combination with either methotrexate, mycophenolate mofetil (MMF) or sirolimus
- Karnofsky performance score ≥ 80 or ECOG ≤ 2
- There must be at least 50% donor chimerism and no evidence of falling donor chimerism within 1 month of enrollment
- Laboratory test results within range, within 14 days prior to initiation of lenalidomide
- All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
Exclusion Criteria:
- Disease progression at time of study entry
- Patients with any grade III-IV GVHD at the time of study entry
- Patients requiring additional immunosuppressive therapy to control acute GVHD other than corticosteroids and immunosuppressive agents used for prophylaxis.
- Concomitant use of other investigational agents
- Patients who have received donor lymphocyte infusions
- Active CNS malignancy
- Uncontrolled bacterial, viral, or fungal infections
- Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ < 5 years from study entry.
- Known hypersensitivity or desquamating rash to either thalidomide or lenalidomide.
- Known positive for HIV or active infectious hepatitis.
- Women who are pregnant or breastfeeding.
- New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Lenalidomide
Lenalidomide maintenance therapy will start within 60 to 180 days after allogeneic HCT at a starting dose of 10mg PO once daily.
Dose escalation and de-escalation are performed depending on tolerability of lenalidomide.
The dose range is 5mg every other day and 5 to 25 mg daily from days 1-21 followed by 7 days of rest for 12 cycles (each cycle 28 days).
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Lenalidomide maintenance therapy will start within 60 to 90 days after allogeneic HCT at a starting dose of 10mg PO once daily. Dose escalation and de-escalation are performed depending on tolerability of lenalidomide. The dose range is 5mg every other day and 5 to 25 mg daily from days 1-21 followed by 7 days of rest for 12 cycles (each cycle 28 days).
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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To determine tolerability and safety profile of a maximum of 12 cycles or 12 months from first dose (which ever comes first) of lenalidomide maintenance therapy post allogeneic hematopoietic cell transplantation for high risk multiple myeloma.
Tidsramme: 12 months
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12 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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To estimate the incidences of ≥ grade 3 adverse events, graft failure, infections, treatment-related mortality (TRM) and incidence and severity of acute and chronic GVHD after initiation of lenalidomide.
Tidsramme: 13 months
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13 months
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To measure the overall response and best response rates to lenalidomide maintenance therapy following allogeneic HCT.
Tidsramme: 13 Months
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13 Months
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To determine time to disease progression and overall survival after lenalidomide.
Tidsramme: 13 months
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13 months
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Melissa Alsina, MD, H. Lee Moffitt Cancer Center
- Studiestol: Marcelo Pasquini, MD, CIBMTR/ Medical College of Wisconsin
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
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
- Fysiologiske effekter av legemidler
- Antineoplastiske midler
- Immunologiske faktorer
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Lenalidomid
Andre studie-ID-numre
- 07-REV
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
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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
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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 lenalidomide
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Sidney Kimmel Comprehensive Cancer Center at Johns...AvsluttetMyelodysplastisk syndromForente stater
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Celgene CorporationICON Clinical ResearchFullførtMyelodysplastiske syndromerTyskland, Israel, Storbritannia, Spania, Belgia, Italia, Frankrike, Nederland, Sverige
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Grupo Español de Linfomas y Transplante Autólogo...Celgene Corporation; Dynamic Science S.L.; Thermo Fisher Scientific, IncFullførtDiffust storcellet B-celle lymfomSpania
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Boston VA Research Institute, Inc.Celgene Corporation; Edward Hines Jr. VA Hospital; Michael E. DeBakey VA... og andre samarbeidspartnereFullførtMultippelt myelomForente stater
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Swiss Group for Clinical Cancer ResearchAvsluttetLymfomSveits, Norge, Sverige
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Dana-Farber Cancer InstituteBeth Israel Deaconess Medical Center; Genentech, Inc.; Brigham and Women's... og andre samarbeidspartnereAvsluttetWaldenstroms makroglobulinemiForente stater
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National Health Research Institutes, TaiwanNational Taiwan University Hospital; China Medical University Hospital; Chang... og andre samarbeidspartnereHar ikke rekruttert ennåPerifere T-celle lymfomer (PTCL)Taiwan
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University Hospital, ToulouseCelgene Corporation; Janssen-Cilag Ltd.FullførtMultippelt myelomFrankrike
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Samsung Medical CenterRekrutteringResidiverende og/eller refraktær non-Hodgkin T-celle lymfomKorea, Republikken