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An Efficacy and Safety Study of Siltuximab in Participants With Relapsed or Refractory Multiple Myeloma

13. května 2014 aktualizováno: Centocor, Inc.

A Phase 2 Multicenter Study of CNTO 328 (Anti IL-6 Monoclonal Antibody) in Subjects With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the safety and efficacy of siltuximab in participants with relapsed (the return of a disease or the signs and symptoms of a disease after a period of improvement.) or refractory (cancer that does not respond to treatment) multiple myeloma (a type of cancer that begins in plasma cells [white blood cells that produce antibodies]).

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

This is an open-label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study), non-randomized (a clinical trial in which the participants are not assigned by chance to different treatment groups), prospective (study following participants forward in time) safety and efficacy study of siltuximab in participants with relapsed or refractory multiple myeloma. The study consists of 3 Phases: Screening Phase (from first visit until the first dose of study drug), Treatment Phase (from the first dose to the end-of-treatment), and Follow-up Phase (after end-of-treatment until the end of study). The duration of participation in the study for an individual participant will be up to 4 weeks for Screening Phase, approximately 52 weeks for Treatment Phase and until death, lost to follow-up, withdraw of consent or end of study, whichever, comes first for Follow-up Phase. Treatment will be administered on a 28-day cycle. The study is designed with 2 alternative treatment plans. Treatment Plan A: during first 2 cycles siltuximab will be administered alone, dexamethasone may be added to the treatment regimen based on the participant's response to treatment. Treatment Plan B: siltuximab and dexamethasone combination for the duration of the study. The first 14 eligible participants will follow Treatment Plan A and data evaluation will be conducted for participants after 2 cycles of treatment and 2 post baseline disease assessments. If at least one complete response (CR) or partial response (PR) is observed in 14 participants, all subsequent participants will follow Treatment Plan A. However, if no responses (CR or PR) are observed, all subsequent participants will follow Treatment Plan B. The primary efficacy endpoint will be percentage of participants with overall response. Participants' safety will be monitored throughout the study.

Typ studie

Intervenční

Zápis (Aktuální)

53

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Holandsko
      • Amsterdam, Holandsko
      • Den Haag, Holandsko
      • Leiden, Holandsko
      • Rotterdam, Holandsko
  • Spojené státy
    • California
      • Duarte, California, Spojené státy
    • Connecticut
      • Norwalk, Connecticut, Spojené státy
    • Indiana
      • Indianapolis, Indiana, Spojené státy
    • Minnesota
      • Rochester, Minnesota, Spojené státy
    • New York
      • New York, New York, Spojené státy
    • North Carolina
      • Chapel Hill, North Carolina, Spojené státy
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Spojené státy
    • South Carolina
      • N Charleston, South Carolina, Spojené státy
    • Texas
      • Houston, Texas, Spojené státy

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Confirmed diagnosis of multiple myeloma with relapsed or refractory disease after failing at least 2 prior lines of therapy
  • Prior treatment regimen must have included bortezomib (alone or in combination with other agents)
  • Measurable secretory disease defined as either serum monoclonal paraprotein (M- protein) greater than or equal to (>=) 1 gram per deciliter (g/dL) or urine monoclonal (light chain) protein (greater than (>) 200 milligram/24 hours)
  • Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to (<=) 2 - Participants of childbearing potential must use adequate birth control measures, female participants of childbearing potential must have a negative serum pregnancy test at screening

Exclusion Criteria:

  • Treatment with systemic cancer therapy (including clarithromycin) or radiotherapy within 30 days before the first dose of study agent - Treatment with nitrosoureas (a group of alkylating agents used as antineoplastic drugs in the chemotherapy) within 42 days before the first dose of study agent
  • Major surgery within 30 days before the first dose of study agent or planning to have surgery (except for minor surgical procedures) during the study
  • Serious concurrent illness (medical or psychiatric), uncontrolled infection, or significant cardiac disease characterized by significant ischemic coronary disease (an imbalance between myocardial functional requirements and the capacity of the coronary vessels to supply sufficient blood flow) or congestive heart failure (condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body) not under medical control, or any uncontrolled medical condition (for example: uncontrolled diabetes), including the presence of clinical laboratory abnormalities, that places the subject at unacceptable risk by participating in the study or confounds the ability to interpret data from the study
  • Known to be seropositive (giving a positive result in a test of blood serum) for Human Immunodeficiency Virus (HIV), or active hepatitis A, B or C infection

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Treatment Plan A
Siltuximab 6 milligram per kilogram (mg/kg) as intravenous (directly into the vein) infusion once every 2 weeks for 12 cycles and duration of each cycle is 28 days (if participant have complete or partial response) along with dexamethasone (starting from Cycle 2, If participant do not have complete or partial response) 40 mg tablet orally on Day 1 to 4, 9 to 12 and 17 to 20 for maximum 4 cycles after that on Day 1 to 4 up to 12 cycles.
Biologický: Siltuximab
Siltuximab 6 mg/kg as intravenous infusion once every 2 weeks for 12 cycles and duration of each cycle is 28 days.
Ostatní jména:
  • CNTO 328
Lék: Dexamethasone
Dexamethasone 40 mg tablet orally on Day 1 to 4, 9 to 12 and 17 to 20 for maximum 4 cycles after that on Day 1 to 4 up to 12 cycles and duration of each cycle is 28 days.
Experimentální: Treatment Plan B
Siltuximab 6 mg/kg as intravenous infusion once every 2 weeks along with dexamethasone 40 mg tablet orally on Day 1 to 4, 9 to 12 and 17 to 20 for maximum 4 cycles (duration of each cycle is 28 days) after that on Day 1 to 4 up to 12 cycles.
Biologický: Siltuximab
Siltuximab 6 mg/kg as intravenous infusion once every 2 weeks for 12 cycles and duration of each cycle is 28 days.
Ostatní jména:
  • CNTO 328
Lék: Dexamethasone
Dexamethasone 40 mg tablet orally on Day 1 to 4, 9 to 12 and 17 to 20 for maximum 4 cycles after that on Day 1 to 4 up to 12 cycles and duration of each cycle is 28 days.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percentage of Participants With Overall Response
Časové okno: Baseline up to end of study (Day 807)
The overall response is defined as percentage of participants having confirmed Complete Response (CR) and Partial Response (PR) by using the European Group for Blood and Marrow Transplantation (EBMT) criteria. CR is absence of the original monoclonal protein (M-protein) in serum and urine maintained for a minimum of 6 weeks, and disappearance of soft tissue plasmacytomas. PR is greater than or equal to (>=) 50 percent reduction in the level of the serum M-protein maintained for a minimum of 6 weeks and >= 50 percent reduction in the size of soft tissue plasmacytomas.
Baseline up to end of study (Day 807)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time to Progression (TTP)
Časové okno: Baseline up to end of study (Day 807)
The TTP is defined as the time interval in days between the date of first administration of study treatment (as monotherapy or as combination therapy) to the date of first documented evidence of confirmed progressive disease (including relapse from CR). CR is absence of the original M-protein in serum and urine maintained for a minimum of 6 weeks, and disappearance of soft tissue plasmacytomas.
Baseline up to end of study (Day 807)
Duration of Response
Časové okno: Baseline up to end of study (Day 807)
The duration of response is defined as the time from initial documented response (Complete Response [CR] or Partial Response [PR]), to the first documented sign of progression. CR is absence of the original M-protein in serum and urine maintained for a minimum of 6 weeks, and disappearance of soft tissue plasmacytomas. PR is >= 50% reduction in the level of the serum M-protein maintained for a minimum of 6 weeks and >= 50% reduction in the size of soft tissue plasmacytomas.
Baseline up to end of study (Day 807)
Number of Participants With Immune Response
Časové okno: Day 1 (Cycle 1 [pre-dose]), treatment discontinuation, and every 3 months after the last dose (up to 3 times)
Immune response is defined as antibody (type of protein that helps to protect the body against foreign matter, such as bacteria and viruses) response to siltuximab.
Day 1 (Cycle 1 [pre-dose]), treatment discontinuation, and every 3 months after the last dose (up to 3 times)
Percent Change From Baseline in C-Reactive Protein (CRP) Level
Časové okno: Before siltuximab administration in Cycles 1, 2, and 3 on Days 1 and 15; thereafter, on Day 1 of each cycle up to12 cycles
Percentage change in CRP is equal to CRP at time of measurement minus CRP at baseline divided by CRP at baseline multiplied by 100.
Before siltuximab administration in Cycles 1, 2, and 3 on Days 1 and 15; thereafter, on Day 1 of each cycle up to12 cycles
Percent Change From Baseline in C-telopeptide (CTx) Level
Časové okno: Before siltuximab administration on Day 1 of cycles 1, 2, and 3
Percentage change in CTx is equal to CTx at time of measurement minus CTx at baseline divided by CTx at baseline multiplied by 100.
Before siltuximab administration on Day 1 of cycles 1, 2, and 3
Percent Change From Baseline in N-telopeptide (NTx) Level
Časové okno: Before siltuximab administration on Day 1 of cycles 1, 2, and 3
Percentage change in NTx is equal to NTx at time of measurement minus NTx at baseline divided by NTx at baseline multiplied by 100.
Before siltuximab administration on Day 1 of cycles 1, 2, and 3

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Centocor, Inc.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. října 2006

Primární dokončení (Aktuální)

1. července 2009

Dokončení studie (Aktuální)

1. července 2009

Termíny zápisu do studia

První předloženo

17. listopadu 2006

První předloženo, které splnilo kritéria kontroly kvality

17. listopadu 2006

První zveřejněno (Odhad)

22. listopadu 2006

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

14. května 2014

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. května 2014

Naposledy ověřeno

1. května 2014

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CR012631
  • C0328T05
  • 2006-001897-26

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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