Clinical trial NCT00718640: An Efficacy and Safety Study of Bortezomib in Participants Previously Treated for Multiple Myeloma With Limited Kidney Function
Official title: Safety and Efficacy of Velcade in Relapsed and/or Refractory Multiple Myeloma Patients With Impaired Renal Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Velcade
Bortezomib
Dexamethasone
Lead sponsor: Janssen-Ortho Inc., Canada
Sponsor class: INDUSTRY
First posted: 2008-07-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of bortezomib in participants previously treated for multiple myeloma (cancer of plasma cells in bone marrow causing numerous tumors and characterized by the presence of abnormal proteins in the blood) with limited kidney function.

Detailed description: This is an open label (all people know the identity of the intervention), multi-center (study conducted at multiple sites), non-comparative, single arm study of bortezomib. The study consists of 3 phases: Screening phase (21 days before Day 1 of cycle 1); Treatment phase (consist of 8 cycles each cycle of 21 days or until disease progression or unacceptable toxicity); and a Follow-up phase (for participants with positive treatment response or stable disease at the final visit). Follow-up for disease progression will be done in every 3 months up to 2 years. Participants who will experience disease progression after completing at least 2 cycles of bortezomib treatment or have no change from baseline in stable disease after completing at least 4 cycles or as per Investigator's discretion will receive dexamethasone. Efficacy will be primarily evaluated by percentage of participants with renal compromised Multiple Myeloma by International Myeloma Working Group (IMWG) uniform response criteria. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with symptomatic multiple myeloma based on the International Myeloma Working Group (IMWG) criteria; greater than or equal to 10 percent plasma cells in the bone marrow (or tissue biopsy) detected, monoclonal protein in the serum or urine and the, presence of end-organ injury
* Participants with measurable disease defined by at least 1 of the following 5 measurements: a) serum M-protein greater than or equal to 1 gram per deciliter (g/dl), b) Urine M Protein greater than or equal to 200 milligram per 24 hour, c) Serum free light chain (FLC) assay: Involved FLC level greater than 10 mg per dl (mg/dl) provided serum FLC ratio is abnormal, d) Bone marrow plasma cells greater than or equal to 30 percent
* Participants who received at least 1 prior line of chemotherapy for multiple myeloma and, is refractory to or has relapsed after the last therapy
* Participants with Karnofsky performance status greater than 60 or Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Participants with calculated or measured creatinine clearance of less than or equal to 30 mililiter per minute (ml/min). During the screening period, 2 measures of creatinine clearance at least 7 days apart must be obtained, and both must be less than 30 ml/min

Exclusion Criteria:

* Participants who had received bortezomib in previous clinical trial and best response was progressive disease or experienced one or more serious events
* Participants who received nitorsoureas within 6 weeks, or 2 consecutive weeks of intense corticosteroids, or immunotherapy or antibody therapy within 4 weeks before enrolment
* Participants with history of allergic reaction attributable to compounds containing boron or mannitol
* Participants with peripheral neuropathy of Grade 2 or greater intensity at the time of signing informed consent form
* Pregnant or breast-feeding female participants

Primary outcomes:
measure: Percentage of Participants With Renal Compromised Multiple Myeloma by International Myeloma Working Group (IMWG) Uniform Response Criteria
timeFrame: Week 24 or Early termination visit (30-45 days after last dose)
Secondary outcomes:
measure: Best Response to Treatment
timeFrame: Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)
measure: Time to Progression (TTP) of Disease
timeFrame: Day 1 (Start of treatment) until the date of first documented evidence of progression of disease or death
measure: Duration of Response
timeFrame: Day 1 (Start of treatment) until the date of first documented achievement of response
measure: Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
timeFrame: Day 1 of Cycle 1, 3, 5, 7 and Final visit/Early termination visit (30-45 days after last dose)
measure: Karnofsky Performance Status (KPS) Score
timeFrame: Day 1 of Cycle 1, 3, 5, 7 and Final visit (30-45 days after last dose) or early termination visit
measure: Quality of Life Assessment by QLQ C-30
timeFrame: Final Visit/Early termination visit (30-45 days after last dose)
measure: Quality of Life Assessed by Euro Quality of Life (EQ-5D)
timeFrame: Quality of Life (EQ-5D) Final Visit/Early termination visit (30-45 days after last dose)
measure: Renal Function
timeFrame: Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)
Other outcomes:
Locations:
city: New Westminster
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Saint John N/A
country: Canada
Study officials:
affiliation: Janssen Inc.
name: Janssen Inc. Clinical Trial
role: STUDY_DIRECTOR
References: