Panobinostat 20mg with bortezomib, dexamethasone, and low-dose thalidomide is a safe and efficacious treatment combination for patients with relapsed multiple myeloma, according to a study published in The Lancet Haematology.1
Findings from the phase 3 PANORAMA 1 trial (ClinicalTrials.gov Identifier: NCT01023308) led to the approval of panobinostat for treatment, in conjunction with bortezomib and dexamethasone, of patients who received at least 2 prior lines of therapy. This treatment regimen was, however, associated with incidence of grade 3-4 diarrhea, nausea, and asthenia.
For the present phase 1/2 MUK-six trial (ClinicalTrials.gov Identifier: NCT02145715), researchers attempted to determine both the optimal and maximum panobinostat dosage, as well as whether administering bortezomib subcutaneously (rather than intravenously, as was done in the PANORAMA 1 trial) and adding low-dose thalidomide would together reduce toxicity but preserve or improve treatment efficacy.
Fifty-seven patients were enrolled; 16 patients were included in a dose-escalation phase to determine the optimal and maximum panobinostat dosage. One dosage-limiting toxicity event was reported at 20mg, and, though this event was not linked to the study regimen, the authors were unable to determine the maximum drug dosage.
RELATED: How Should Maintenance Therapy for Multiple Myeloma Be Prescribed?
The researchers concluded that the optimal panobinostat dosage is 20mg. The intention-to-treat population included 46 patients; of this group, 91% achieved a partial response or better, and 46% achieved a very good partial response or better. The incidence of grade 3-4 events was also lower than in the PANORAMA 1 trial.
Panobinostat 20mg is, according to the authors, an efficacious and relatively safe treatment, in combination with bortezomib, dexamethasone, and thalidomide, in this patient population.
- Popat R, Brown SR, Flanagan L, et al. Bortezomib, thalidomide, dexamethasone, and panobinostat for patients with relapsed multiple myeloma (MUK-six): a multicentre, open-label, phase 1/2 trial. Lancet Haematol. 2016 Nov 11. doi: 10.1016/S2352-3026(16)30165-X [Epub ahead of print]