Multiple Myeloma Clinical Trial
Official title:
Consolidation Therapy With Bortezomib <= 60 Year Old Patients With Multiple Myeloma
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.
Status | Completed |
Enrollment | 217 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen-Cilag G.m.b.H |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No | |
Secondary | Response rates | 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. | Up to Week 25 | No |
Secondary | Overall survival | Time interval in months between the date of randomization and the participant's death from any cause. | 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 | Yes |
Secondary | Time to progression | Time to progression is time interval in months until progression of disease, censoring for death or drop-out without 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 | No |
Secondary | Duration of response | 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. | Up to Week 25 | No |
Secondary | Number of patients with toxicities over the treatment period | Toxicities will be assessed according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3. | Up to Week 24 | Yes |
Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) | 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. | Baseline (Day 1), Enpoint (30-60 months) | No |
Secondary | Number of the patients with skeletal related event (SRE) | Pathological fracture, spinal cord compression, radiotherapy of a bone lesion, surgical therapy of a bone lesion will be considered as skeletal related events. | Up to 30-60 months | Yes |
Secondary | Time interval from the day of the transplantation up to the occurrence of the first SRE | Up to 30-60 months | Yes | |
Secondary | Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to 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. | Baseline (Day 1) and end point (30-60 months) | No |
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