A Phase 2 interventional study of Bortezomib in Multiple Myeloma, sponsored by Janssen-Cilag International NV. Completed at 39 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-12.
Sponsored by Janssen-Cilag International NV · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of bortezomib in participants with multiple myeloma who have previously responded to a bortezomib based therapy.
This is an Open-Label (all people know the identity of the intervention), non-randomized, multicenter (when more than one hospital or medical school team work on a medical research study), single arm study to evaluate the safety and efficacy of bortezomib in participants with multiple myeloma (cancer of the types of cells normally found in bone marrow) who have previously responded to a bortezomib based therapy. Participants will be non-randomly assigned to single group bortezomib. Participants will be treated with bortezomib alone or in combination with another drug (dexamethasone). Bortezomib will be given intravenously (i.v. [into a vein]) twice Weekly, on Days 1, 4, 8 and 11 of each cycle followed by a 10-day (Days 12 to 21) rest period. The total duration of treatment period will be 8 cycles, each lasting 3 weeks. The initial bortezomib dose is the last tolerated dose (1.0 or 1.3 milligram per metersquare [mg/ m\^2] on the previous bortezomib-based treatment. Participants who start the study on a dose of 1.0 mg/m\^2 bortezomib and tolerate the dose well could have their dose escalated to 1.3 mg/m\^2. Doses above 1.3 mg/m\^2 are not allowed. A complete cycle comprises 4 doses of bortezomib. Dexamethasone will be first introduced in Cycles 1 to 5 (i.e.dexamethasone will not be introduced for the first time in Cycles 6 to 8). The median total dose of dexamethasone received per cycle ranges from 120 mg (cycle 7) to 160 mg (cycles 1 to 6 and 8). Efficacy will be primarily assessed by determining Best Confirmed Response according to the European Group for Blood and Marrow Transplantation (EBMT) criteria. Participant's safety will be monitored throughout the study.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 130 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Janssen-Cilag International NV is the lead sponsor of 66 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Bortezomib
Bortezomib will be given intravenously (into a vein) twice weekly, on Days 1, 4, 8 and 11 and then a 10-day (Days 12 to 21) rest period, of each 3-week cycle for up to a total of 8 cycles. The initial bortezomib dose is 1.0 or 1.3 milligram per meter square (mg/m\^2) depending on the previous bortezomib-based treatment, up to a maximum dose of 1.3 mg/m\^2. Participants will receive bortezomib in combination with or without dexamethasone, in accordance with the standard of care. The median total dose of dexamethasone per cycle ranges from 120 mg (Cycle 7) to 160 mg (Cycles 1 to 6 and 8).
Best Confirmed Response to Bortezomib Re-Treatment
Number of participants with best confirmed response to bortezomib Re-Treatment will be assessed by the European Group for Blood and Marrow Transplantation (EBMT) criteria. Best confirmed response is, if administration of bortezomib provide continuing or additional clinical benefit after previous bortezomib administration. The ordering of possible responses are Complete Response (CR), Partial Response (PR), Minimal Response (MR), No Change (NC) and Progressive Disease (PD)/relapse from CR. CR is the best response and the poorest response is PD or relapse from CR.
Time frame: Day 1 of every alternate cycle starting from Cycle 1 up to End of Treatment (30 to 42 days after last dose administration of bortezomib)
Participants With Percent Change in Baseline Serum Monoclonal Protein (M-protein) Best Confirmed Response Category
Number of participants with percent change in baseline serum M-protein best confirmed response category will be assessed by EBMT criteria. Best confirmed response is, if administration of bortezomib provide continuing or additional clinical benefit after previous bortezomib administration. Decrease in serum M-protein levels from baseline represents improvement. Participants having baseline M-protein value of \<5 gram per liter (g/L) (serum) or \<200 mg/24 hour (urine) will be classed in 'Not Evaluable' category and any response rate (RR) which is unconfirmed will be classed as 'Missing'.
Time frame: Day 1 of every alternate cycle starting from Cycle 1 up to End of Treatment (30 to 42 days after last dose administration of bortezomib)
Participants with Percent Change in Baseline Urine Monoclonal Protein (M-protein) Best Confirmed Response Category
Number of participants with percent change in baseline Urine M-protein best confirmed response category will be assessed by EBMT criteria. According to EBMT best confirmed response is, if administration of bortezomib provide continuing or additional clinical benefit after previous bortezomib administration. Decrease in urine M-protein levels from baseline represents improvement. Participants having baseline M-protein value of \<5 g/L (serum) or \<200 mg/24 hour(urine) will be classed in 'Not Evaluable' category and any RR which is unconfirmed will be classed as 'Missing'.
Time frame: Day 1 of every alternate cycle starting from Cycle 1 up to End of Treatment (30 to 42 days after last dose administration of bortezomib)
Duration of Best Confirmed Response (DOR)
The DOR is defined as the duration (months) from the date of the first evidence of a best confirmed response to the date of first documented evidence of PD (or relapse for participants who experienced CR). The PD or relapse are defined as one or more of following criteria: \>25% increase in either serum or urine M-protein, \>25% increase in plasma cells on bone marrow, Definite increase in size of bone lesion or plasmacytoma, Development of new bone lesion or plasmacytoma, Development of hypercalcaemia. The DOR will be calculated separately in participants with a best confirmed response of \>=PR.
Time frame: Day 1 Cycle 1 up to last follow-up visit (8 weeks until PD)
Time to Progression (TTP) for Best Confirmed Response
The TTP is defined as the duration (in months) from the date of first study treatment administration (enrollment at Day 1, Cycle 1) until the date of first documented evidence of PD (or relapse for participants who experienced CR). PD or relapse are defined as one or more of the following criteria: -\>25% increase in either serum or urine M-protein. -\>25% increase in plasma cells on bone marrow. -Definite increase in size of bone lesion or plasmacytoma. -Development of new bone lesion or plasmacytoma. -Development of hypercalcaemia
Time frame: (Day 1 Cycle 1 up to last follow-up visit date (8 weeks until PD)
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Janssen-Cilag International NV