An Efficacy and Safety Study of Bortezomib in Participants Previously Treated for Multiple Myeloma With Limited Kidney Function

NCT00718640 | Terminated Phase 2 Results

• 2 other identifiers: CR01508226866138MMY2052
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Velcade; Bortezomib; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Renal Compromised Multiple Myeloma by International Myeloma Working Group (IMWG) Uniform Response Criteria

  The IMWG uniform response criteria define; Complete response(CR) as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow(BM). Stringent CR as CR+normal free light chain ratio and absence of clonal cells in BM Very good partial response (PR) as serum and urine M-protein (monoclonal paraprotein) detectable by immunofixation but not on electrophoresis or 90% or \>reduction in serum and urine M-protein level \<100 milligram(mg) per 24 hour(hr).PR as \<=50% reduction of serum and \<= 90% of urine M-protein or up to \<200 mg/24 hr.

  Week 24 or Early termination visit (30-45 days after last dose)

Secondary Outcomes (8)

• Best Response to Treatment

  Day 1 of Cycle 1, 2, 3, 4, 5, 5, 6, 7, 8 and Final/Early termination visit (30-45 days after last dose)

• Time to Progression (TTP) of Disease

  Day 1 (Start of treatment) until the date of first documented evidence of progression of disease or death

• Duration of Response

  Day 1 (Start of treatment) until the date of first documented achievement of response

• Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score

  Day 1 of Cycle 1, 3, 5, 7 and Final visit/Early termination visit (30-45 days after last dose)

• Karnofsky Performance Status (KPS) Score

  Day 1 of Cycle 1, 3, 5, 7 and Final visit (30-45 days after last dose) or early termination visit

Study Arms (1)

Bortezomib and Dexamethasone

EXPERIMENTAL

Bortezomib 1.3 milligram (mg) per meter\^2 (m\^2) bolus (a large amount) intravenous (into the vein) injection will be administered once daily on Days 1, 4, 8 and 11 of each 21-day cycle with addition of Dexamethasone 20 mg per day administered orally, once daily on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-day cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).

Drug: Dexamethasone; Drug: Bortezomib

Interventions

Dexamethasone DRUG

Dexamethasone 20 mg per day will be administered orally on Days 1 and 2, Days 4 and 5, Days 8 and 9 and Days 11 and 12 of each 21-days cycle as per Investigator's discretion for those participants who experience disease progression after treatment completion up to Cycle 2 or have no change from Baseline after completion of at least 4 cycles. The treatment will be given up to 8 cycles (24 weeks).

Bortezomib and Dexamethasone

Bortezomib DRUG

Bortezomib 1.3 milligram per meter\^2 (mg/m\^2), bolus intravenous injection will be administered on Days 1, 4, 8 and 11 of each 21-day cycle and up to 8 cycles.

Also known as: Velcade

Bortezomib and Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead

Study Sites (5)

Unknown Facility

New Westminster, British Columbia, Canada

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Greenfield Park, Quebec, Canada

Location

Unknown Facility

Saint John, Canada

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dexamethasone; Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Participants' recruitment was limited due to pre-defined criteria of renal disease and requirement of repeated evaluation of creatinine clearance. Due to insufficient number of participants the outcome measure data was not analyzed.

Results Point of Contact

• Title: Director, Medical Affairs Oncology
• Organization: Janssen Inc., Canada

416-382-5078

Study Officials

• Janssen Inc. Clinical Trial

  Janssen Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2008
• First Posted: July 21, 2008
• Study Start: October 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: October 29, 2013
• Results First Posted: August 28, 2013

Record last verified: 2013-09

Locations

CA (5)