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Bortezomib, Cyclophosphamide, Dexamethasone, and Thalidomide in Treating Patients With Newly Diagnosed, Previously Untreated Multiple Myeloma

12 maart 2009 bijgewerkt door: Fred Hutchinson Cancer Center

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.

Studie Overzicht

Toestand

Onbekend

Conditie

Multipel myeloom en plasmacelneoplasma

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Verwacht)

Fase

Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Verenigde Staten
- California
  - Berkeley, California, Verenigde Staten, 94704
    - Alta Bates Summit Comprehensive Cancer Center
  - Los Angeles, California, Verenigde Staten, 90048
    - Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
  - Palm Springs, California, Verenigde Staten, 92262
    - Desert Regional Medical Center Comprehensive Cancer Center
  - Sacramento, California, Verenigde Staten, 95816
    - Sutter Cancer Center
- Florida
  - Boca Raton, Florida, Verenigde Staten, 33486
    - Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
- New York
  - New York, New York, Verenigde Staten, 10011
    - St. Vincent's Comprehensive Cancer Center - Manhattan
- Oregon
  - Portland, Oregon, Verenigde Staten, 97239
    - Oregon Health and Science University Cancer Institute
- Texas
  - Austin, Texas, Verenigde Staten, 78759
    - Lone Star Oncology - Austin
- Washington
  - Seattle, Washington, Verenigde Staten, 98109-1023
    - Seattle Cancer Care Alliance
  - Seattle, Washington, Verenigde Staten, 98109-1024
    - Fred Hutchinson Cancer Research Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Masker: Geen (open label)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Responspercentage

Secundaire uitkomstmaten

Uitkomstmaat
Veiligheid en verdraagzaamheid

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fred Hutchinson Cancer Center

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

Hoofdonderzoeker: William I. Bensinger, MD, Fred Hutchinson Cancer Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 augustus 2006

Primaire voltooiing (Verwacht)

1 december 2008

Studieregistratiedata

Eerst ingediend

20 februari 2007

Eerst ingediend dat voldeed aan de QC-criteria