Multiple Myeloma MedDRA version: 14.0 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Velcade
Product Name: bortezomib
Pharmaceutical Form: Solution for injection
INN or Proposed INN: bortezomib (PS-341)
CAS Nu
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i. Previously untreated patients with symptomatic myeloma ii. Patients suitable for high dose therapy and ASCT iii. = 18 years of age iv. Performance score (PS) of 0-3 (ECOG) v. Measurable disease as defined by one of the following: a. Secretory myeloma: Monoclonal protein in the serum or monoclonal light chain in the urine (Bence Jones protein =200mg/24hours), or serum free light chain (SFLC, involved light chain =100mg/L provided the FLC ratio is abnormal) b. Non-secretory myeloma: =30% plasma cells in the marrow (aspirate and/or biopsy) and at least one plasmacytoma =2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan) vi. Adequate full blood count within 14 days before registration: a. Platelet count =75x109/L b. Absolute neutrophil count (ANC) =1x109/L vii. Adequate renal function within 14 days before registration: a. Creatinine clearance >30ml/min viii. Adequate hepatobiliary function within 14 days before registration: a. Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i. Grade 2 peripheral neuropathy or neuropathic pain as defined by NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) ii. Pregnant or breast-feeding iii. Unwilling to use adequate contraception during the study and for 6 months after the end of the study treatment if female of childbearing potential(WCBP), or male whose partner is WCBP iv. Known history of allergy contributable to compounds containing boron or mannitol v. Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the patient’s participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: What is the 2-year progression-free survival (PFS) for patients who, having achieved CR/VGPR following PAD therapy, do not receive any further treatment until clinical indication of relapse? This question is addressed separately for patients who are minimal residual disease positive (MRD+), and those who are MRD negative (MRD-), at end of induction chemotherapy.;Secondary Objective: a. What is the overall response rate (CR/VGPR and PR) to PAD therapy in previously untreated patients with multiple myeloma? b. What percentage of patients become MRD negative as determined by multi-parameter flow (MPF) following PAD therapy? c. What percentage of patients proceeding to ASCT become MRD- at 100 days post-ASCT? d. What is the PFS of patients proceeding to ASCT? e. Does the level of activation of the Nfkappa-B pathway influence response rate and PFS in patients receiving PAD induction therapy for untreated MM?;Primary end point(s): Progression free survival (PFS) in patients assigned to no further treatment until clinical indication of relapse. This will be determined for MRD+ and MRD- patients separately. PFS is defined as the time from date of PBSCH to date of the first progression/relapse or date of death from all causes whichever occurs first. | — |
Countries
United Kingdom
Outcome results
None listed