Multiple Myeloma
Conditions
Keywords
Multiple Myeloma, Bortezomib, PS341, Proteasome inhibitor, Consolidation therapy
Brief summary
The purpose of this study is determination of the event-free survival with and without Bortezomib consolidation therapy from the day of the first chemotherapeutic, myeloma-specific therapy measure, up to the occurrence of progression/recurrence or up to the occurrence of death.
Detailed description
This is a two-arm (group), open-label (all people know the identity of the intervention), prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study) randomized (the study medication is assigned by chance), multi-center study. Approximately 385 patients will be enrolled in this study. Patients will be randomly assigned to treatment or observation group in a ratio of 1:1. The study duration from screening up to the study end is up to 27 weeks. Then the patients will be observed until the last included patient has completed a 30 month post observational phase. The patients in the treatment arm will receive 4 cycles of a therapy. Each cycle lasts for a 35 days. Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, and clinical laboratory tests.
Interventions
DRUGBortezomib
Bortezomib will be administered as 1.6 mg/m2 per body surface area on the days 1, 8, 15, 22 for the duration of 4 therapy cycles.
DRUGNo intervention
Participants in the observation group will be observed and will not receive any consolidation therapy.
Sponsors
Janssen-Cilag G.m.b.H
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with multiple myeloma with prior therapy consisting of remission induction therapy and high dose chemotherapy followed by stem cell transplantation * Women must be postmenopausal or using safe contraception methods * Creatinin clearance has to be higher than 30 ml/min and whole blood count has to be within acceptable ranges
Exclusion criteria
* No asecretory multiple myeloma * History of allergic reactions to bortezomib or mannitol * Expected life expectancy of less than 3 months * No other malignant disease beside basalioma either existing or history of * No history of severe cardio-pulmonary disease * Seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with event-free survival (PFS) | From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rates | Up to Week 25 | Response will be determined according to EBMT (European Group for Blood and Marrow Transplantation) criteria; VGPR (very good partial response) will be added as an additional response criteria. VGPR is measured as at least 90 percents reduction of the monoclonal protein in the serum over at least 6 weeks. |
| Overall survival | From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled | Time interval in months between the date of randomization and the participant's death from any cause. |
| Time to progression | From date of first chemotherapeutic myeloma-specific treatment measure until date of disease progression or death, whichever occurred first, as assessed approximately 30-60 months after the last participant was enrolled | Time to progression is time interval in months until progression of disease, censoring for death or drop-out without progression. |
| Duration of response | Up to Week 25 | Duration of the response, measured from the day on which a response (at least minimal response) was documented for the first time after the start of the therapy, up until the day of the documentation of a progression/recurrence requiring therapy. |
| Number of patients with event free survival (EFS) | From date of first chemotherapeutic myeloma-specific treatment measure until the occurrence of the beginning of a new chemotherapeutic therapy,or death, whichever occurred first, as assessed approximately 30-60 months after the last patient was enrolled | — |
| Change From Baseline in European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) | Baseline (Day 1), Enpoint (30-60 months) | EORTC QLQ-C30 is a questionnaire to assess quality of life of cancer patients. It is composed of 30 items, multi-item measure (28 items) and 2 single-item measures. For the multiple item measure, 4-point scale is used and the score for each item range from 1 = not at all to 4 = very much. Higher scores indicate worsening. The 2 single-item measure involves question about the overall health and overall quality of life which will be rated on a 7-point scale ranging from 1 = very poor to 7 = excellent. Lower scores indicate worsening. |
| Number of the patients with skeletal related event (SRE) | Up to 30-60 months | Pathological fracture, spinal cord compression, radiotherapy of a bone lesion, surgical therapy of a bone lesion will be considered as skeletal related events. |
| Time interval from the day of the transplantation up to the occurrence of the first SRE | Up to 30-60 months | — |
| Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to end point (30-60 months) | Baseline (Day 1) and end point (30-60 months) | Change from Baseline to end point (30-60 months) in Euro Quality of life (Qol)-5 Dimension Questionnaire (EQ-5D). A higher score indicates an improvement in health in the Health Status Index. The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating full health and 0 representing dead. |
| Number of patients with toxicities over the treatment period | Up to Week 24 | Toxicities will be assessed according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3. |
Countries
Germany
Outcome results
None listed