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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 gennaio 2017 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

250

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

65 anni e precedenti (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: MPV followed by Revlimid/Low Dose Dexamethasone (Rd)
Melphalan/Prednisone/Velcade (MPV) followed by Revlimid/Low Dose Dexamethasone (Rd)
Droga: Prednisone
Droga: Melfalan
Droga: Velcade
Sperimentale: Alternating MPV with Revlimid/Low Dose Dexamethasone
Alternating Velcade/Melphalan/Prednisone (MPV) with Revlimid/Low Dose Dexamethasone (Rd)
Droga: Desametasone
Droga: Revimid

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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.
Lasso di tempo: 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
Lasso di tempo: 6 months
6 months

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
To evaluate the response in both groups of patients
Lasso di tempo: 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
Lasso di tempo: 2 years
2 years
Duration of response in two groups of patients
Lasso di tempo: 2 years
2 years
Progression free survival (PFS) in two different groups of patients
Lasso di tempo: 18 months
18 months
Time to next therapy (TNT)
Lasso di tempo: 2 years
2 years
Overall survival (OS) in the two different groups of patients
Lasso di tempo: 5 years
5 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

PETHEMA Foundation

Collaboratori

Celgene
Janssen-Cilag Ltd.
TFS Trial Form Support

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2011

Completamento primario (Effettivo)

1 agosto 2014

Completamento dello studio (Effettivo)

1 maggio 2016

Date di iscrizione allo studio

Primo inviato

4 novembre 2010

Primo inviato che soddisfa i criteri di controllo qualità

7 novembre 2010

Primo Inserito (Stima)

9 novembre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 gennaio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 gennaio 2017

Ultimo verificato

1 gennaio 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GEM2010MAS65

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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