Relapsed or refractory Multiple Myeloma
Conditions
Interventions
Product Name: Bortezomib
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Bortezomib
Current Sponsor code: PS 341
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type
Sponsors
All Ireland co-operative Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients aged at least 18 years with MM requiring therapy for relapsed or refractory disease. •Previous VAD or VAD-like therapy (maximum 6 courses standard VAD). Subgroup allocation is shown in 4.1 •Measurable serum and/or urine paraprotein, or serum free light chain •Performance Status (PS) 0-3 (ECOG - see Appendix B) •Serum bilirubin values =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients with Acute Diffuse Infiltrative Pulmonary Disease (ADIPD) •Patients with Pericardial disease •Females of child-bearing potential without a negative pregnancy test, immediately prior to the start of PAD therapy and/or unwilling to use barrier contraceptive precautions throughout the study or who are pregnant or breast-feeding •Men with partners of child bearing potential unwilling to use a medically acceptable form of contraception •Patients with non-secretory MM and no measurable elevation of serum free light chain •Performance status 4 (ECOG) •Patient has a platelet count 400 umol/l at the time of enrolment •Patient has >_Grade 2 peripheral neuropathy or neuropathic pain as defined by NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE) within 14 days before enrolment •Cardiac ejection fraction 5 years) of other cured tumours may be entered •Plasma exchange within 21 days of enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To assess the response (PR and CR) in patients with myeloma previously treated with a maximum of 6 courses of VAD (Vincristine, Adriamycin and Dexamethasone) or VAD-like regimen and who have relapsed or are refractory to VAD, when treated with PAD.;Secondary Objective: •To assess safety and toxicity of PAD therapy in previously treated patients •To determine the progression free survival and overall survival in patients treated with PAD •Comparison of original response to VAD to response obtained with PAD using 1 % fall in paraprotein or Bence Jones Protein 2 lowest level of abnormal protein achieved 3 duration of response •Feasibility of stem cell collection to be undertaken in age and fitness eligible refractory patients not already transplanted. ;Primary end point(s): The primary endpoint of study is to determine the response ratio (CR & PR) to PAD therapy in each of the three treatment groups. | — |
Countries
Ireland, United Kingdom
Outcome results
None listed