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

12 de março de 2009 atualizado por: 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.

Visão geral do estudo

Status

Desconhecido

Condições

Mieloma múltiplo e neoplasia de células plasmáticas

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

Estágio

Fase 2

Contactos e Locais

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Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Finalidade Principal: Tratamento
Mascaramento: Nenhum (rótulo aberto)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Taxa de resposta

Medidas de resultados secundários

Medida de resultado
Segurança e tolerabilidade

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Fred Hutchinson Cancer Center

Colaboradores

National Cancer Institute (NCI)

Investigadores

Investigador principal: William I. Bensinger, MD, Fred Hutchinson Cancer Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de agosto de 2006

Conclusão Primária (Antecipado)

1 de dezembro de 2008

Datas de inscrição no estudo

Enviado pela primeira vez

20 de fevereiro de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ