A Study of Bortezomib as Consolidation Therapy in Patients With Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00416273|
Recruitment Status : Completed
First Posted : December 27, 2006
Last Update Posted : March 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Bortezomib Drug: No intervention||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||217 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Consolidation Therapy With Bortezomib <= 60 Year Old Patients With Multiple Myeloma|
|Study Start Date :||December 2006|
|Primary Completion Date :||May 2013|
|Study Completion Date :||May 2013|
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.
- 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 ]
- 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 ]
- Response rates [ Time Frame: 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 [ 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 ]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 ]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 ]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 ]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) ]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 ]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 ]
- 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) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416273
|Frankfurt / Main, Germany|
|Study Director:||Janssen-Cilag G.m.b.H, Germany Clinical Trial||Janssen-Cilag G.m.b.H|