TriangleNCT00657553 · REGISTRY CONDITION SEARCH
Preemptive Strike With Bortezomib in Multiple Myeloma Patients
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE3
- Status at capture
- TERMINATED
- Registry last update
- 2017-11-20
To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.
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.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Diagnosed with multiple myeloma currently or previously enrolled on UARK 98-026 and currently event-free at the time of the evaluation. * Performance status of 0-2 based of Southwest Oncology Group (SWOG) criteria * Previously documented platelet count \> 75,000/ul within a 35 days prior to enrollment * Previously documented peripheral absolute neutrophil count \>1,000/ul within 35 days prior to enrollment. * Adequate renal function * Signed informed consent * Female subject is post-menopausal or willing to use acceptable birth control * Male subjects agree to use acceptable method of contraceptive Exclusion Criteria: * Hypersensitivity to Bortezomib, boron, or mannitol * Female subject is pregnant or breastfeeding * Experienced myocardial infraction within 6 months prior to enrollment * Received other investigational new drugs within 14 days before enrollment * Received any anti-myeloma therapy within 14 days * Serious medical or psychiatric illness likely to interfere with participation in this clinical study * Diagnosed or treated for another malignancy within 3 years of enrollment
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Bortezomib Maintenance Year 1 - bortezomib days 1, 4, 8, 11 every 28 days Year 2 - bortezomib days 1, 4, 8, 11 every 2 months Year 3 - bortezomib days 1, 4, 8, 11 every 3 months
- intervention Names
- Drug: Bortezomib
- label
- Bortezomib/Treatment Arm
- type
- ACTIVE_COMPARATOR
- description
- monitor myeloma parameters every 3-6 months
- label
- Observation Arm (watchful waiting)
- type
- NO_INTERVENTION
- interventions
- arm Group Labels
- Bortezomib/Treatment Arm
- description
- Year 1:1.0 mg/m2. IV. Days 1, 4, 8, 11 every 4 weeks Year 2: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 8 weeks Year 3: 1.0 mg/m2. IV. Days 1, 4, 8, 11 every 12 weeks
- name
- Bortezomib
- other Names
- Velcade
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 10
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The number of patients on Bortezomib that have maintained event-free survival, compared to the patients on observation was not analyzed due to low attrition rates. Event-free survival is a measure of the proportion of people who remain free of a particular complication of disease (called an event) after treatment that is designed to prevent or delay that particular complication.
- measure
- Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2
- time Frame
- three years
Full study description
- brief Summary
- To evaluate whether using the drug bortezomib at the start of remission will prevent relapse for a longer period of time.
- detailed Description
- Although advances in the treatment of multiple myeloma have led to improved remission rates, the risk for serious relapse is very high. The drug Bortezomib has been highly effective for treatment of the disease in an advanced stage such as post-transplant relapse. Due to the need of maintenance therapies, it is necessary to look to certain drugs that may prolong remission and increase the quality of life. Bortezomib, when taken at the beginning of remission, may prove to be a beneficial maintenance drug for the management of multiple myeloma.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-07cfa1685c8b4d2bca59
- requested nct id
- NCT00657553
- primary nct id
- NCT00657553
- source kind
- ctgov_condition_query
- source record id
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- source file sha256
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- payload
- clinical indication matching status
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- end exclusive
- true
- id
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- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
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- occurrences
- context exact
- NCT00657553
- end
- 11
- exact text
- NCT00657553
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Plasma Cell Neoplasms
- query disease state id
- ds-plasma-cell-neoplasms
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
- source file sha256
- 2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
- source json pointer
- /studies/739/protocolSection/identificationModule/nctId
- source kind
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- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- a556c4d163c19f26a6629897758ebf60197bc9f64b4439f829c14ec8a3dbc9fb
Preserved source evidence · Not medical advice