Multiple Myeloma
Conditions
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.
Interventions
DRUGBortezomib
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
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2 | three years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Bortezomib will be administered as 12 monthly courses of 1.0 mg/m2 on days 1, 4, 8, and 11 and repeated every 28 days, followed by cycles administered every other month in year 2, and then every 3 months in year 3 | 5 |
| Observation Arm Patients will be observed for progress over the course of three years. | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | low accrual, no analysis run | 5 | 5 |
Baseline characteristics
| Characteristic | Treatment Arm | Observation Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Continuous | 61.6 years STANDARD_DEVIATION 7.89 | 64.4 years STANDARD_DEVIATION 7 | 63 years STANDARD_DEVIATION 7.3 |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Effect of Maintenance Therapy With Bortezomib on the Length of Remission in Participants Currently Receiving Maintenance Therapy as Part of Total Therapy 2
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.
Time frame: three years