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S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Phase 2
Terminated
Conditions
Multiple Myeloma
Interventions
Registration Number
NCT00124579
Lead Sponsor
SWOG Cancer Research Network
Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It may also stop the growth of cancer by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with thalidomide and dexamethasone may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide and dexamethasone works in treating patients with relapsed or refractory multiple myeloma.

Detailed Description

OBJECTIVES:

* Determine the confirmed overall response rate (complete remission, remission, and partial remission) in patients with relapsed or refractory multiple myeloma treated with bortezomib, thalidomide, and dexamethasone.

* Determine overall and progression-free survival of patients treated with this regimen.

* Determine the qualitative and quantitative toxic effects of this regimen in these patients.

* Correlate, preliminarily, treatment with bortezomib with the activation of osteoblasts in these patients.

OUTLINE: This is a multicenter study.

* Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11, oral thalidomide once daily on days 1-21, and oral dexamethasone once daily on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days until achievement of confirmed complete remission (CR), remission (R), or partial remission (PR) OR for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients achieving confirmed CR, R, or PR who reach a plateau prior to receiving the maximum 8 courses of induction therapy OR who achieve confirmed CR, R, or PR after receiving the maximum 8 courses of induction therapy proceed to maintenance therapy. Patients achieving stable disease after receiving the maximum 8 courses of induction therapy either proceed to maintenance therapy or receive further treatment with bortezomib, thalidomide, and dexamethasone off-study.

* Maintenance therapy: Patients receive oral dexamethasone on days 1-4. Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed within 30 days and then every 6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 18 months.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
7
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
bortezomib with thalidomide and dexamethasonebortezomibbortezomib with thalidomide and dexamethasone
bortezomib with thalidomide and dexamethasonedexamethasonebortezomib with thalidomide and dexamethasone
bortezomib with thalidomide and dexamethasonethalidomidebortezomib with thalidomide and dexamethasone
Primary Outcome Measures
NameTimeMethod
Overall Response Rate Complete Remission (CR), Remission (R), and Partial Remission (PR).1 year

Responses are defined as follows:

Complete Remission: Absence of bone marrow or blood findings of multiple myeloma. This includes disappearance of all evidence of serum and urine M-proteins on immunofixation electrophoresis studies. Normalization of serum concentrations of normal immunoglobulins is not required for CR. There must also be no evidence of increasing anemia. Bone marrow cellularity must be ≥ 20% with plasma cells ≤ 5%.

Remission: A ≥ 75% reduction in the serum M-protein, and if a urine M-protein (Bence-Jones protein) is present, either a ≥ 90% reduction in this protein, or a urine M-protein \< 0.2gm/day. Bone marrow plasma cells must be ≤ 5%.

Partial Remission: A ≥ 50% reduction in the serum M-protein, and if present, a ≥ 50% reduction in the urine M-protein (Bence-Jones protein). Bone marrow plasma cells must not be increased from baseline level.

Secondary Outcome Measures
NameTimeMethod
Progression-Free Survivalabout 12-18 months

From date of initial registration to date of progression/relapse of disease (\> 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.) or death from any cause, whichever came first, up to 5 years

Toxicity EvaluationFrom date of protocol therapy start to date of protocol therapy end, i.e., up to about 3.5 years

To evaluate the qualitative and quantitative toxicities associated with this regimen.

Trial Locations

Locations (126)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

Saint Anthony's Hospital at Saint Anthony's Health Center

🇺🇸

Alton, Illinois, United States

Good Samaritan Regional Health Center

🇺🇸

Mount Vernon, Illinois, United States

Hematology Oncology Consultants - Naperville

🇺🇸

Naperville, Illinois, United States

Regional Cancer Center at Memorial Medical Center

🇺🇸

Springfield, Illinois, United States

St. Francis Hospital and Health Centers - Beech Grove Campus

🇺🇸

Beech Grove, Indiana, United States

Reid Hospital & Health Care Services, Incorporated

🇺🇸

Richmond, Indiana, United States

Genesis Regional Cancer Center at Genesis Medical Center

🇺🇸

Davenport, Iowa, United States

Genesis Medical Center - West Campus

🇺🇸

Davenport, Iowa, United States

Tammy Walker Cancer Center at Salina Regional Health Center

🇺🇸

Salina, Kansas, United States

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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States

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