Dinaciclib is not yet approved in the U.S. or anywhere else in the world as a treatment for any kind of cancer. It is still being researched.
Moreover, as best I can tell, clinical trials of dinaciclib have focused so far on the drug's potential as a treatment for melanoma, rather than myeloma.
However, a Phase 2 trial of dinaciclib as a potential treatment for relapsed / refractory multiple myeloma patients has just been started by the Mayo Clinic. Full details about the trial can be found here.
I am not yet sure whether we will do a full article about dinaciclib (or the Phase 2 trial) here at the Myeloma Beacon. Thus, if anyone can provide further information about either the drug or the trial, please go ahead and post what you know as replies to this posting. That way, this thread can become a useful reference about dinaciclib and its potential use as a myeloma treatment.
In the meantime, allow me to pass along some basic information.
First, in regard to the drug itself ... Dinaciclib is administered as an intravenous infusion over two hours. Patients receive one infusion every three weeks, for a maximum of 12 courses of therapy. The drug belongs to a class of potential new anti-cancer treatments called CDK inhibitors.
Second, in regard to qualifying for the Phase 2 trial, the participation criteria are as follows (these are the key points; the complete list is available at the trial description):
Disease Characteristics:
- Diagnosis of relapsed or refractory multiple myeloma
- Measurable disease as defined by ≥ 1 of the following:
- Serum monoclonal protein ≥ 1.0 g/dL
- More than 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
- Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
- Not a candidate for stem cell transplantation or has had stem cells collected previously
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- ANC ≥ 1,000/multiple myeloma^3
- Platelet count ≥ 75,000/multiple myeloma^3
- Hemoglobin ≥ 8 g/dL
- Total serum bilirubin normal
- AST/ALT ≤ 2.5 upper limit of normal
- Creatinine < 2.5 mg/dL
- No more than 4 prior therapies for this disease (stem cell transplantation and preceding induction therapy will be considered as 1 therapy)
- More than 3 weeks since prior myelosuppressive therapy for myeloma AND recovered from acute reversible adverse events
- More than 2 weeks since prior non-myelosuppressive agents (e.g., thalidomide or high dose corticosteroids)
- No concurrent high dose corticosteroids
- Concurrent corticosteroids allowed provided patients are on chronic steroids (maximum dose 20 mg/day prednisone equivalent) if they are being given for disorders other than amyloid (i.e., adrenal insufficiency, rheumatoid arthritis, etc.)
- No other concurrent investigational agents
- Concurrent bisphosphonates allowed
