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NCT00287872 · REGISTRY CONDITION SEARCH

Bortezomib and Thalidomide in Treating Patients With Newly Diagnosed Stage II or Stage III Multiple Myeloma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2018-03-01

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide works in treating patients with newly diagnosed stage II or stage III multiple myeloma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Clinical Response to Treatment

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outcome · POSTED

Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher)

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outcome · POSTED

Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation

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outcome · POSTED

The Time to Response

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outcome · POSTED

Quality of Life

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Newly diagnosed Salmon-Durie stage II or III multiple myeloma * Untreated disease OR patient underwent prior therapy for this cancer that lasted no more than 2 weeks * Measurable paraprotein in serum or urine (serum free-lite assay measurement allowed) * No evidence of cord compression requiring concurrent steroids PATIENT CHARACTERISTICS: * Creatinine clearance ≥ 30 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 methods of contraception, including ≥ 1 highly effective method, 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment * No known HIV positivity * No peripheral neuropathy ≥ grade 2 * No hypersensitivity to bortezomib, boron, or mannitol PRIOR CONCURRENT THERAPY: * No prior bortezomib * More than 28 days since prior regimens with a duration of \> 1 week but ≤ 2 weeks * No steroids within 14 days prior to study entry * No concurrent corticosteroids except for the treatment of a nonmalignant condition * May not exceed the equivalent dose of prednisone 10 mg/day * No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery * No other concurrent investigational agents
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.
    intervention Names
    1. Drug: bortezomib
    2. Drug: thalidomide
    label
    Bortezomib and Thalidomide
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Bortezomib and Thalidomide
    name
    bortezomib
    other Names
    1. VELCADE
    type
    DRUG
  2. arm Group Labels
    1. Bortezomib and Thalidomide
    name
    thalidomide
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
30
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Clinical evaluations of disease response were determined with each cycle. Bone marrow biopsies were done at baseline and at study termination. Clinical responses were defined by the International Myeloma Working Group criteria: Stringent Complete Response (SCR), CR and normal free light chain ratio and no clonal cells in bone marrow; Complete Response (CR), Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; Very Good Partial Response (VGPR), Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; Partial Response (PR), ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. Objective response is defined as a best overall response of SCR, CR, VGPR, or PR.
    measure
    Clinical Response to Treatment
    time Frame
    1-6 months
secondary Outcomes
  1. description
    Neuropathy was monitored using Total Neuropathy Score reduced (TNSr).
    measure
    Peripheral Motor and Sensory Neuropathy (Grade 2 and Higher)
    time Frame
    1-6 months
  2. measure
    Mobilization of Stem Cells in Patients Proceeding to Autologous Peripheral Stem Transplantation
    time Frame
    1-6 months
  3. measure
    The Time to Response
    time Frame
    1-6 months
  4. measure
    Quality of Life
    time Frame
    0-6 months
Full study description
brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with thalidomide may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide works in treating patients with newly diagnosed stage II or stage III multiple myeloma.
detailed Description
OBJECTIVES: * Determine the antitumor efficacy of bortezomib and thalidomide in patients with newly diagnosed stage II or III multiple myeloma. * Determine the incidence and severity of peripheral motor/sensory neuropathy in patients treated with this regimen. * Assess the ability to mobilize and collect stem cells in patients who undergo future autologous peripheral stem cell transplantation. * Determine the time to response in patients treated with this regimen. * Assess the quality of life of patients treated with this regimen. OUTLINE: This is an open-label study. Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral thalidomide once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses. Patients who plan to undergo transplantation AND achieve ≥ 50% reduction in the tumor burden proceed to transplantation off study. Patients who do not undergo transplantation receive 2 additional courses of therapy beyond best response for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response after completion of treatment may receive maintenance therapy comprising bortezomib IV every 2 months and oral thalidomide\* once daily OR twice every 2 months (i.e., the day before and the day of bortezomib administration) in the absence of disease progression or unacceptable toxicity. NOTE: \*For patients who had previously discontinued thalidomide, maintenance therapy may consist of bortezomib only. Quality of life is assessed at baseline, at the beginning of each study course, and after completion of study treatment. After completion of study treatment, patients are followed every 3 months. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Source references
references
  1. citation
    Ghosh N, Ye X, Ferguson A, Huff CA, Borrello I. Bortezomib and thalidomide, a steroid free regimen in newly diagnosed patients with multiple myeloma. Br J Haematol. 2011 Mar;152(5):593-9. doi: 10.1111/j.1365-2141.2010.08534.x. Epub 2011 Jan 17.
    pmid
    21241279
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      query cond
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      source file
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    Preserved source evidence · Not medical advice