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Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 65 Years With Sequential Melphalan/Prednisone/Velcade (MPV) Followed by Revlimid/Low Dose Dexamethasone (Rd) Versus Alternating Velcade/Melphalan/Prednisone (MPV) With Revlimid/Low Dose Dexamethasone

16. januar 2017 oppdatert av: PETHEMA Foundation

A National, Open-label, Multicenter, Randomized, Comparative Phase IIb Study of Treatment for Newly Diagnosed Multiple Myeloma Patients Older Than 65 Years With Sequential Melphalan/Prednisone/Velcade (MPV) Followed by Revlimid/Low Dose Dexamethasone (Rd) Versus Alternating Velcade/Melphalan/Prednisone (MPV) With Revlimid/Low Dose Dexamethasone (Rd).

This is a national, multicenter, open-label, randomized, comparative study designed to compare, first, the TTP of the two treatment schemes proposed (MPV followed by Rd or MPV alternating with Rd) in newly diagnosed MM patients older than 65 years. This comparison will be performing in terms of both efficacy and safety. Up to 120 patients will be included in each treatment arm and evaluated at scheduled visits in up to 3 study periods: Pre-treatment, Treatment and Follow-up.

Primary outcome measure:

  • To evaluate the efficacy in terms of time to progression (TTP) at 18 months of MPV and Rd used as either in a sequential or alternating approach in newly diagnosed MM patients older than 65 years.
  • To evaluate the toxicity (safety and tolerability) of the sequential versus the alternating use of MPV and Rd.

Secondary outcome measure:

  • To evaluate the response, duration of response, progression free survival (PFS), time to next therapy (TNT) and overall survival (OS) in the two different groups of patients.
  • To identify, within the group of patients treated with the alternating scheme, the biological characteristics (including a comprehensive genomic analysis) of those patients resistant to one or the other, and patients refractory to both treatments

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The Pre-treatment period includes Screening visit. After providing written informed consent form to participate in the study, patients will be evaluated for eligibility during a screening period of 14 days (Days -14 to -1). If patients meet all inclusion and exclusion criteria will be randomized at the moment of entry in the trial in a 1:1 allocation to receive either MPV followed by Rd (Treatment Group A) or MPV alternating with Rd (Treatment Group B).

Patients in the Treatment Group A will receive nine cycles of MPV consisting on one 6-weeks cycle of Velcade (Bortezomib) as an intravenous bolus twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32) followed by a 10 day rest period (day 33 to 42), in combination with oral Melphalan, once daily on days 1 to 4 and oral Prednisone, once daily on days 1 to 4, followed by eight 4-weeks cycles of Velcade (Bortezomib) as an intravenous bolus on days 1, 8, 15 and 22 followed by a 6 day rest period (days 23 to 28), in combination with Melphalan and Prednisone per os once daily on days 1 to 4, followed by a 24-day rest period (days 5 to 28). After the nine MPV cycles, patients will receive nine cycles of Rd consisting on 4-weeks cycles, including Revlimid (lenalidomide), once daily on days 1-21 followed by a 7 day rest period (days 22 to 28) plus oral dexamethasone, once weekly on days 1,8,15 and 22, followed by a 6 day rest period (days 23 to 28).

Patients in the Treatment Group B will receive the same schedule of therapy, but the MPV cycles will be alternated with Rd cycles. In this treatment Group B, patients will be again randomized to start receiving either MPV or Rd as first cycle of therapy. Overall, patients will receive an identical number of cycles, nine cycles of MPV and nine of Rd. Patients randomized to Treatment Group A relapsing/progressing or with major toxicities under treatment with MPV will be crossover to receive Rd, but only after study coordinator approval.

During the Treatment Period, patients will be evaluated at day 1 of each cycle. After completion of the Treatment Period, all patients will be evaluated every 2 months thereafter.

Safety will be assessed by the monitoring of adverse events, physical examinations, vital signs measurements, and haematology and clinical chemistry test. Response to treatment will be based on EBMT an IMWG criteria. Response to treatment will be evaluated at day 1 of each induction cycle, and every 2 months during thereafter.

Studietype

Intervensjonell

Registrering (Faktiske)

250

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
      • Alcorcón, Spania
        • Fundacion Hospital Alcorcon
      • Badalona, Spania
        • Hospital de Badalona Germans Trias i Pujol
      • Barcelona, Spania
        • Hospital del Mar
      • Barcelona, Spania
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spania
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spania
        • H. Vall d'Hebron, Barcelona
      • Barcelona, Spania
        • ICO - Duran i Reynals, Hospitalet de Llobregat
      • Bilbao, Spania
        • Hospital de Cruces
      • Castellón, Spania
        • Hospital General de Castellon
      • Ciudad Real, Spania
        • Hospital General
      • Cuenca, Spania
        • Hospital Virgen de la Luz
      • Cáceres, Spania
        • Complejo Hospitalario de Cáceres
      • Cádiz, Spania
        • Hospital Puerta del Mar
      • Donostia, Spania
        • Hospital Donostia
      • Gandía, Spania
        • Hospital Francesc Borja
      • Girona, Spania
        • ICO - Josep Trueta
      • Guadalajara, Spania
        • Hospital General de Guadalajara
      • Jerez de la Frontera, Spania
        • H. de Jerez
      • Leon, Spania
        • Complejo Hospitalario León
      • Madrid, Spania
        • Hospital Ramon y Cajal
      • Madrid, Spania
        • Hospital La Paz
      • Madrid, Spania
        • Hospital Clinico San Carlos
      • Madrid, Spania
        • Hospital De Fuenlabrada
      • Madrid, Spania
        • Hospital Infanta Leonor
      • Madrid, Spania
        • Hospital de La Princesa
      • Madrid, Spania
        • Hospital del Tajo
      • Madrid, Spania
        • Hospital Universitario Gregorio Maranon
      • Madrid, Spania
        • Hospital Severo Ochoa
      • Madrid, Spania
        • Hospital Infanta Sofía
      • Madrid, Spania
        • Clínica Puerta de Hierro
      • Madrid, Spania
        • Hospital 12 de Octubre. Madrid
      • Madrid, Spania
        • Hospital de Madrid, S.A.- Norte Hospital General
      • Madrid, Spania
        • MD Anderson
      • Manresa, Spania
        • Althaia
      • Murcia, Spania
        • Hospital Virgen de la Arrixaca
      • Murcia, Spania
        • Hospital General Univeristario Morales Messeguer
      • Málaga, Spania
        • Complejo Hospital Costa Del Sol
      • Málaga, Spania
        • Hospital Nuestra Senora de Valme
      • Navarra, Spania
        • Hospital de la Diputación de Navarra
      • Palma de Gran Canaria, Spania
        • Hospital de Gran Canaria Doctor Negrín
      • Palma de Mallorca, Spania
        • Complejo Asistencial Son Dureta
      • Pamplona, Spania
        • Hospital Virgen del Camino
      • Sabadell, Spania
        • Corporacio Sanitaria Parc Tauli
      • Salamanca, Spania
        • Hospital Clínico de Salamanca
      • Santander, Spania
        • Hoaspital Marqués de Valdecilla
      • Santiago de Compostela, Spania
        • Complejo Hospitalario Universitario de Santiago
      • Segovia, Spania
        • Hospital General de Segovia
      • Sevilla, Spania
        • Complejo Hospitalario Regional Virgen del Rocío
      • Tarragona, Spania
        • Hospital Joan XXIII
      • Tenerife, Spania
        • Hospital Universitario de Canarias
      • Toledo, Spania
        • Hospital Virgen de la Salud
      • Toledo, Spania
        • Hospital Nuestra Señora del Prado
      • Valencia, Spania
        • Hospital Arnau de Vilanova
      • Valencia, Spania
        • Hospital Universitario Dr. Peset
      • Valencia, Spania
        • Hospital La Fe
      • Valencia, Spania
        • Hospital Clínico de Valencia.
      • Vitoria, Spania
        • Hospital Txagorritxu
      • Zamora, Spania
        • Hospital Virgen de la Concha
      • Zaragoza, Spania
        • Hospital Clinico Lozano Blesa
      • Zaragoza, Spania
        • Miguel Servet
    • Baleares
      • Palma de Mallorca, Baleares, Spania
        • H. Son Llatzer
    • Madrid
      • Alcalá de Henares, Madrid, Spania
        • Hospital Príncipe de Asturias
    • Navarra
      • Pamplona, Navarra, Spania
        • Clinica Universitaria de Navarra

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Written informed consent obtained before starting any study-specific procedure.
  2. Symptomatic elderly MM newly diagnosed by EBMT criteria older than 65 years.
  3. Performance status (ECOG) ≤ 2.

  4. Have pre-treatment clinical laboratory values meeting the following criteria within 14 days of randomization:

    • platelet count ≥ 75x109/L
    • haemoglobin ≥ 8g/dL
    • absolute neutrophil count (ANC) ≥ 1.0x109/L
    • Serum bilirubin ≤ 1.5 mg/dL and alkaline phosphatise ≤ 2.5 x ULN AST, ALT ≤ 2.5 x ULN
    • Serum creatinine ≤2,5 mg/dl

Exclusion Criteria:

  1. Patient previously received treatment with Velcade or Revlimid.
  2. Patient previously received treatment for Multiple Myeloma.
  3. Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrolment.
  4. Patient has hypersensitivity to bortezomib, boron, mannitol or lenalidomide.
  5. Patient has received other investigational drugs with 28 days before enrolment.
  6. Patient had a myocardial infarction within 6 months of enrolment or has 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.
  7. Patient currently is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.
  8. Radiation therapy within 30 days before randomization, at least patient has had antialgic radiation. Radiation therapy will be afterwards permitted during the treatment period if it is indicated due to the presence of plasmacytomas

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: MPV followed by Revlimid/Low Dose Dexamethasone (Rd)
Melphalan/Prednisone/Velcade (MPV) followed by Revlimid/Low Dose Dexamethasone (Rd)
Legemiddel: Prednison
Legemiddel: Melphalan
Legemiddel: Velcade
Eksperimentell: Alternating MPV with Revlimid/Low Dose Dexamethasone
Alternating Velcade/Melphalan/Prednisone (MPV) with Revlimid/Low Dose Dexamethasone (Rd)
Legemiddel: Deksametason
Legemiddel: Revlimid

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
To evaluate the efficacy in terms of time to progression (TTP) at 18 months of MPV and Rd used as either in a sequential or alternating approach in newly diagnosed MM patients older than 65 years.
Tidsramme: 18 months
18 months
To evaluate the toxicity (safety and tolerability) of the sequential versus the alternating use of MPV and Rd,in terms of adverse events presented in both groups of patients
Tidsramme: 6 months
6 months

Sekundære resultatmål

Resultatmål
Tidsramme
To evaluate the response in both groups of patients
Tidsramme: 1 year
1 year
To identify, within the group of patients treated with the alternating scheme, the biological characteristics (including a comprehensive genomic analysis) of those patients resistant to one or the other, and patients refractory to both treatments
Tidsramme: 2 years
2 years
Duration of response in two groups of patients
Tidsramme: 2 years
2 years
Progression free survival (PFS) in two different groups of patients
Tidsramme: 18 months
18 months
Time to next therapy (TNT)
Tidsramme: 2 years
2 years
Overall survival (OS) in the two different groups of patients
Tidsramme: 5 years
5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

PETHEMA Foundation

Samarbeidspartnere

Celgene
Janssen-Cilag Ltd.
TFS Trial Form Support

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. februar 2011

Primær fullføring (Faktiske)

1. august 2014

Studiet fullført (Faktiske)

1. mai 2016

Datoer for studieregistrering

Først innsendt

4. november 2010

Først innsendt som oppfylte QC-kriteriene

7. november 2010

Først lagt ut (Anslag)

9. november 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

18. januar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. januar 2017

Sist bekreftet

1. januar 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GEM2010MAS65

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