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Bortezomib and High-dose Melphalan at Myeloma Relapse

17. juni 2010 opdateret af: Nordic Myeloma Study Group

Phase II Study of Bortezomib Dexamethasone and High-dose Melphalan in Patients With Relapse After High-dose Melphalan With Autologous Stem Cell Support

The prognosis after retreating with high-dose melphalan with stem cell support after first relapse after high-dose treatment is dependent on the time to first relapse. Bortezomib can increase chemosensitivity of e.g. melphalan. The trial aims at determining the toxicity of adding bortezomib to high-dose melphalan with stem cell support and evaluating whether the time to a second relapse can be prolonged.

Studieoversigt

Status

Ukendt

Betingelser

Myelomatose

Intervention / Behandling

Medicin: bortezomib

Detaljeret beskrivelse

Patients with multiple myeloma who have their first treatment demanding relapse after an initial treatment with high-dose melphalan with autologous stem cell support and who have more than 2.0 x 10^6 CD34+ stem cells pr kg bodyweight in the freezer can be included in the trial.

After disease status with basic clinical biochemistry, M-protein in blood and urine, bone marrow investigation including immunophenotyping and total skeletal x-ray the patients are treated with three courses of standard bortezomib (1.3 mg/sqm Days 1,4,8,11) and dexamethasone 20 mg days 1,2,4,5,8,9,11,12. Within 4 weeks the patients receive bortezomib days -5 and -2, high-dose melphalan (200 mg/sqm) day -2, and subsequent at least 2.0 x 10^6 CD34+ stem cells pr kg body weight.

The first month after high-dose therapy the patients are followed closely for toxicity according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE), Version 3.0.

The patients are evaluated for response according to EBMT criteria and for event (death or progressive disease).

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Danmark
- - Aalborg, Danmark, 9000
    - Department of Haematology B, Aalborg Hospital, University of Aarhus
  - Herlev, Danmark, 2730
    - Department of Haematology, Herlev University Hospital
  - Odense, Danmark, 5000
    - Department of Haematology X, Odense University Hospital
  - Århus, Danmark, 8000
    - Dept. of Haematology, Århus University Hospital
Norge
- - Bergen, Norge, N-5021
    - Hematologisk seksjon, med avd, Haukeland Universitetssykehus
  - Oslo, Norge
    - Department of Hematology, Rikshospitalet
  - Trondheim, Norge, N-7006
    - Hematologisk seksjon, St.Olav Hospital
Sverige
- - Göteborg, Sverige
    - Department of Hematology, Sahlgrenska Sjukhuset
  - Lund, Sverige, SE-221 85
    - University Hospital Lund

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

First relapse after ASCT
Symptomatic myeloma
More than 2,0 x 10^6 CD34+ stem cells / kg bodyweight in the freezer for stem cell support
Signed informed consent given prior to any study related activities have been performed
Age > 18 years

Exclusion Criteria:

Allogeneic transplantation scheduled as a part of the treatment
Expected survival of less than one month.
Performance status (WHO) > 3
Neuropathy > Grade 3 (neurological symptoms interfering with ADL)
Non-secreting myeloma
Other concurrent disease making bortezomib treatment unsuitable
Positive pregnancy test (only applicable for women with childbearing potential)
Has known or suspected hypersensitivity or intolerance to melphalan, dexamethasone, boron, mannitol, or heparin, if an indwelling catheter is used
Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
History of hypotension or has decreased blood pressure (sitting systolic blood pressure [SBP] <= 100 mmHg and/or sitting diastolic blood pressure [DBP] <= 60 mmHg)
Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Have received an experimental drug or used an experimental medical device within 4 weeks prior to inclusion into the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Ikke-randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
Comparison of the event free survival after first high-dose melphalan with stem cell support (ASCT) and a second ASCT combined with bortezomib treatment of first relapse Tidsramme: 3 years	3 years

Sekundære resultatmål

Resultatmål	Tidsramme
Determining the toxicity of bortezomib as part of the high-dose melphalan conditioning Tidsramme: 3 years	3 years
Response rate of the second ASCT Tidsramme: 3 years	3 years
Marrow regeneration Tidsramme: 3 years	3 years
OS compared with the OS of matched controls from the former NMSG Tidsramme: 3 years	3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nordic Myeloma Study Group

Samarbejdspartnere

Janssen-Cilag Ltd.

Efterforskere

Ledende efterforsker: Peter Gimsing, M.D., Department of Haematology, Rigshospitalet

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2007

Primær færdiggørelse (Faktiske)

1. juni 2009

Studieafslutning (Forventet)

1. september 2010

Datoer for studieregistrering

Først indsendt

26. juli 2007

Først indsendt, der opfyldte QC-kriterier