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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 januari 2017 uppdaterad 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

250

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

65 år och äldre (Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: MPV followed by Revlimid/Low Dose Dexamethasone (Rd)
Melphalan/Prednisone/Velcade (MPV) followed by Revlimid/Low Dose Dexamethasone (Rd)
Läkemedel: Prednison
Läkemedel: Melphalan
Läkemedel: Velcade
Experimentell: Alternating MPV with Revlimid/Low Dose Dexamethasone
Alternating Velcade/Melphalan/Prednisone (MPV) with Revlimid/Low Dose Dexamethasone (Rd)
Läkemedel: Dexametason
Läkemedel: Revlimid

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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.
Tidsram: 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
Tidsram: 6 months
6 months

Sekundära resultatmått

Resultatmått
Tidsram
To evaluate the response in both groups of patients
Tidsram: 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
Tidsram: 2 years
2 years
Duration of response in two groups of patients
Tidsram: 2 years
2 years
Progression free survival (PFS) in two different groups of patients
Tidsram: 18 months
18 months
Time to next therapy (TNT)
Tidsram: 2 years
2 years
Overall survival (OS) in the two different groups of patients
Tidsram: 5 years
5 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

PETHEMA Foundation

Samarbetspartners

Celgene
Janssen-Cilag Ltd.
TFS Trial Form Support

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2011

Primärt slutförande (Faktisk)

1 augusti 2014

Avslutad studie (Faktisk)

1 maj 2016

Studieregistreringsdatum

Först inskickad

4 november 2010

Först inskickad som uppfyllde QC-kriterierna

7 november 2010

Första postat (Uppskatta)

9 november 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

18 januari 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 januari 2017

Senast verifierad

1 januari 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • GEM2010MAS65

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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