A Study of Bortezomib as Consolidation Therapy in 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Consolidation Therapy With Bortezomib <= 60 Year Old Patients With Multiple Myeloma|
- Number of patients with event-free survival (PFS) [ Time Frame: 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 ] [ Designated as safety issue: No ]
- Number of patients with event free survival (EFS) [ Time Frame: 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 ] [ Designated as safety issue: No ]
- Response rates [ Time Frame: Up to Week 25 ] [ Designated as safety issue: No ]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 [ Time Frame: 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 ] [ Designated as safety issue: Yes ]Time interval in months between the date of randomization and the participant's death from any cause.
- Time to progression [ Time Frame: 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 ] [ Designated as safety issue: No ]Time to progression is time interval in months until progression of disease, censoring for death or drop-out without progression.
- Duration of response [ Time Frame: Up to Week 25 ] [ Designated as safety issue: No ]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 toxicities over the treatment period [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]Toxicities will be assessed according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.
- Change From Baseline in European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) [ Time Frame: Baseline (Day 1), Enpoint (30-60 months) ] [ Designated as safety issue: No ]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) [ Time Frame: Up to 30-60 months ] [ Designated as safety issue: Yes ]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 [ Time Frame: Up to 30-60 months ] [ Designated as safety issue: Yes ]
- Change From Baseline in EuroQol-5 (EQ-5D) Health Status Index to end point (30-60 months) [ Time Frame: Baseline (Day 1) and end point (30-60 months) ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2006|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment group
Participants in the treatment group will receive Bortezomib at a dosage of 1.6 mg/m2.
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.
Experimental: Observation group
Participants in the observation group will not receive any consolidation therapy.
Drug: No intervention
Participants in the observation group will be observed and will not receive any consolidation therapy.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416273
|Frankfurt / Main, Germany|
|Study Director:||Janssen-Cilag G.m.b.H, Germany Clinical Trial||Janssen-Cilag G.m.b.H|