- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00438841
Bortezomib, Cyclophosphamide, Dexamethasone, and Thalidomide in Treating Patients With Newly Diagnosed, Previously Untreated Multiple Myeloma
A Phase II Trial With VELCADE® (PS-341), Cytoxan (Cyclophosphamide), Dexamethasone and Thalomid® (VEL-CTD) in Previously Untreated Multiple Myeloma Patients
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with cyclophosphamide, dexamethasone, and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with cyclophosphamide, dexamethasone, and thalidomide works in treating patients with newly diagnosed, previously untreated multiple myeloma.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
Primary
- Determine the response rate in patients with newly diagnosed, previously untreated multiple myeloma treated with bortezomib, cyclophosphamide, dexamethasone, and thalidomide.
Secondary
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive bortezomib IV on days 1, 4, 8, and 11; cyclophosphamide IV on days 1 and 8 of courses 1-3; oral thalidomide once daily on days 1-21 beginning in course 4; and dexamethasone IV or orally once daily on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
California
-
Berkeley, California, Forente stater, 94704
- Alta Bates Summit Comprehensive Cancer Center
-
Los Angeles, California, Forente stater, 90048
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
-
Palm Springs, California, Forente stater, 92262
- Desert Regional Medical Center Comprehensive Cancer Center
-
Sacramento, California, Forente stater, 95816
- Sutter Cancer center
-
-
Florida
-
Boca Raton, Florida, Forente stater, 33486
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
-
-
New York
-
New York, New York, Forente stater, 10011
- St. Vincent's Comprehensive Cancer Center - Manhattan
-
-
Oregon
-
Portland, Oregon, Forente stater, 97239
- Oregon Health and Science University Cancer Institute
-
-
Texas
-
Austin, Texas, Forente stater, 78759
- Lone Star Oncology - Austin
-
-
Washington
-
Seattle, Washington, Forente stater, 98109-1023
- Seattle Cancer Care Alliance
-
Seattle, Washington, Forente stater, 98109-1024
- Fred Hutchinson Cancer Research Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma meeting 1 of the following criteria:
Monoclonal immunoglobulin spike on serum electrophoresis (IgG > 3.5 g/dL or IgA > 2.0 g/dL) and kappa or lambda light chain excretion > 1 g/day by 24-hour urine protein electrophoresis AND meets any of the following criteria:
- Bone marrow plasmacytosis (10-30% plasma cells)
- Lytic bone lesions
Monoclonal immunoglobulin of lesser magnitude present and bone marrow plasmacytosis (10-30% plasma cells) AND meets any of the following criteria:
- Lytic bone lesions
- IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL
Bone marrow plasmacytosis (> 30% plasma cells) or plasmacytoma on tissue biopsy AND meets any of the following criteria:
- Monoclonal immunoglobulin of lesser magnitude present
- Lytic bone lesions
- IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL
- FreeLite testing abnormal and kappa:lambda light chain ratio abnormal
Symptomatic disease requiring treatment
- Documented related organ or tissue involvement, if present
Measurable disease, defined as 1 of the following:
- Monoclonal immunoglobulin spike on serum electrophoresis ≥ 1 g/dL and/or urine monoclonal immunoglobulin spike ≥ 200 mg/day
- Abnormal FreeLite testing (for nonsecretors)
Patients with nonsecretory disease must meet either of the following criteria for measurability:
- Has measurable protein by FreeLite testing
- Untreated soft tissue plasmacytoma and/or evaluable disease in bone marrow
- Newly diagnosed, previously untreated disease
- No POEMS syndrome (i.e., plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein], and skin changes)
- No plasma cell leukemia
PATIENT CHARACTERISTICS:
- Karnofsky performance status 50-100%
Platelet count ≥ 100,000/mm³ (≥ 50,000/mm³ if bone marrow is extensively infiltrated)
- Extensive infiltration is defined as > 50% myeloma cells or plasma cells
- Hemoglobin ≥ 8.5 g/dL
- Absolute neutrophil count ≥ 1,500/mm³
- AST and ALT ≤ 2 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN (unless clearly related to the disease)
- Creatinine clearance ≥ 20 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 methods of effective contraception ≥ 4 weeks prior to beginning treatment, during, and for ≥ 4 weeks after completion of study treatment
- No impaired kidney function requiring dialysis
- No uncontrolled infection
- No HIV positivity
- No known active hepatitis B or C
No cardiovascular disease including, but not limited to, any of the following:
- Myocardial infarction within the past 6 months
- New York Heart Association class II-IV heart failure
- Uncontrolled angina
- Severe uncontrolled ventricular arrhythmias
- Clinically significant pericardial disease
- Acute ischemic or active conduction system abnormalities by EKG
- No history of allergic reactions to compounds containing mannitol, bortezomib, or cyclophosphamide
- No second malignancy requiring concurrent treatment
- No other serious medical or psychiatric illness that would preclude study compliance
- No peripheral neuropathy ≥ grade 1
PRIOR CONCURRENT THERAPY:
No prior chemotherapy, immunotherapy, vaccine therapy, therapeutic doses of steroids, or other agents for the treatment of active myeloma
- Drugs given to prevent onset of myeloma allowed
- Bisphosphonates for hypercalcemia or short course corticosteroids for hypercalcemia or cord compromise allowed
- Prior local radiotherapy with or without a brief exposure to steroids allowed
More than 4 weeks since prior and no concurrent radiotherapy
- Spot radiotherapy to ≤ 3 vertebrae allowed
- No concurrent steroids at > 10 mg of prednisone daily (or the equivalent) for other medical conditions (e.g., asthma, systemic lupus erythematosus, or rheumatoid arthritis)
- No other concurrent chemotherapy or investigational agents
- Concurrent daily acetylsalicylic acid required during course 4-6 of study treatment
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
Svarprosent
|
Sekundære resultatmål
Resultatmål |
---|
Sikkerhet og toleranse
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: William I. Bensinger, MD, Fred Hutchinson Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Hematologiske sykdommer
- Hemoragiske lidelser
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Multippelt myelom
- Neoplasmer, plasmacelle
- Plasmacytom
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antiemetika
- Gastrointestinale midler
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, hormonelle
- Antineoplastiske midler, Alkylering
- Alkyleringsmidler
- Myeloablative agonister
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Antibakterielle midler
- Leprostatiske midler
- Deksametason
- Cyklofosfamid
- Thalidomid
- Bortezomib
Andre studie-ID-numre
- CDR0000536219
- FHCRC-2123.00
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på cyklofosfamid
-
The Christie NHS Foundation TrustAvsluttetCD19 Positivt Non-Hodgkin lymfomStorbritannia
-
Uprety ShraddhaPostgraduate Institute of Medical Education and ResearchUkjent
-
Yonsei UniversityFullførtBrystkreftKorea, Republikken
-
National Institute of Blood and Marrow Transplant...UkjentAplastisk anemi IdiopatiskPakistan
-
University of Alabama at BirminghamGenentech, Inc.; Ortho Biotech, Inc.FullførtInvasiv brystkreftForente stater
-
Lagos State UniversityUkjentHematologisk abnormitetNigeria
-
German Breast GroupGerman Adjuvant Breast Cancer GroupFullført
-
Auxilio Mutuo Cancer CenterUkjentInfiltrerende kanal- og lobulært karsinom in situ | Invasiv lobulært brystkarsinom | Inflammatorisk brystkarsinomPuerto Rico
-
Memorial Sloan Kettering Cancer CenterFullførtNon-Hodgkins lymfom | CNS lymfom | CNS hjernekreftForente stater