PADIMAC
Trial overview
Phase II strudy of Bortezomib, Adriamycin and Dexamethasone (PAD) therapy for previously untreated patients with multiple myeloma: Impact of minimal residual disease (MRD) in patients with deferred ASCT.
The overall aim of the trial is to provide a reliable estimate of the 2-year PFS for patients who receive no further treatment after achieving a major response to induction therapy with PAD.
Inclusion criteria
- Previously untreated patients with symptomatic myeloma.
- Patients suitable for high-dose therapy and ASCT.
- Patients older than 18 years of age.
- Performance score (PS) of 0-3 (ECOG).
- Measurable disease as defined by one of the following:
~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).
~Non-secretory myeloma: > 30% plasma cells in the marrow (aspirate and/or biopsy) and at least one plasmacutoma > 2 cm as determined by clinical examination or applicable radiographs (i.e. MRI or CT scan).
- Adequate full blood count within 14 days before registration:
~Platelet count > 75x109/L.
~Abosolute neutrophil count (ANC) > 1x109/L.
- Adequate renal function within 14 days before registration:
~Creatinine clearance > 20ml/min (calculated as per local biochemistry protocols).
- Adequate hepatobiliary function within 14 days before registration:
~Total bilirubin < 2 x upper limit of normal (ULN).
~ALT/AST < 2.5 x ULN.
- Adequate pulmonary function:
~No evidence of a history of infiltrative pulmonary disease. If a history, then KCO/DLCO (Carbon Monoxide diffusion in the lung) > 50% and/or no requirement for supplementary continuous O2.
- Adequate cardiac function:
~Left ventricular ejection fraction > 40% by echocardiogram or MUGA scan if local practice.
- If female and of childbearing potential, must have a negative pregnancy test (either serum or urine HCG).
- Able to give informed consent.
Exclusion criteria
- Grade 2 or worse peripheral neuropathy or neuropathic pain as defined by NCI Common Terminology Criteria for Adverse Events verson 4.0.
- Pregnant or breast-feeding.
- Unwilling to use adequate contraception during the study and for 6 months after the end of the study treatment if female of childbearing potential, or male whose partner is a female of childbearing potential.
- Known history of allergy contributable to compunds containing boron or mannitol.
- Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the patient's participation in this study.
Contact details
Other trials currently active for Multiple Myeloma
A non-interventional observational post authorisation safety study of subjects treated with lenalidomide
Myeloma XI is intended to be a unifying trial addressing issues in patients of all ages and providing a strategy within which to introduce new treatments as they become available.
There are two distinct treatment pathways.
Intensive pathway: for younger/fitter patients where intensive HDT with stem cell support is considered appropriate. Comparing a thalidomide-containing regimen with a lenalidomide-containing regimen, as induction treatment prior to HDT.
Non-intensive pathway: for older/less fit patients where standard-dose chemotherapy is considered appropriate. To compare an attenuated thalidomide-containing regimen with an attenuated lenalidomide-containing regimen.