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Pomalidomide, bortezomib, and dexamethasone combination chemotherapy is efficacious and safe for the treatment of newly diagnosed multiple myeloma.

Multiple myeloma (MM) is an incurable disease. Currently, treatment aims to improve the quality of life and overall survival of these patients. The established standard treatment in newly diagnosed multiple myeloma (NDMM) cases consists of bortezomib, lenalidomide, and dexamethasone induction chemotherapy (VRd) with subsequent autologous stem cell transplantation (ASCT). 

Drugs originally used to treat relapsed and/or refractory MM (RRMM) are now also being evaluated for their effectiveness in treating NDMM. Pomalidomide is an immunomodulatory drug approved for RRMM. However, its benefit in NDMM has not been well-studied. A phase II trial was recently conducted to evaluate the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (VPd) induction for NDMM. The findings of this trial were published in Blood Cancer Journal.

 Study Population

This prospective study incorporated 34 patients with NDMM. Thirty-one patients who completed a minimum of 4 cycles of chemotherapy were followed up for a median period of 14 months to assess the response. The median age was 52 years. 

Efficacy Assessment

Accomplishing a good response rate is the cornerstone for the treatment of NDMM. In this study, VPd induction garnered a 100% response rate. Moreover, 87% patients achieved ≥ very good partial response (VGPR) or better and 61% achieved complete response (CR) or better as per the International Myeloma Working Group (IMWG) uniform response criteria, and 48% showed a complete metabolic response on PET-CT. This regimen showed a higher rate of ≥VGPR responses, as compared to the conventional VRd regimen.

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 Safety Evaluation

VPd induction showed an acceptable safety profile in this study. It was found to be safe in patients of old age and with comorbidities. During the trial, one death was directly attributable to chemotherapy. Common (≥10%) adverse effects were neutropenia (24% of patients), anemia (21%), and thrombocytopenia (15%). The most common non-hematological adverse events included peripheral sensory neuropathy (27%), fatigue (27%), and constipation (24%).

 Stem Cell Transplantation

In the study group, 87% of patients were found to be eligible for ASCT. Of these, 35% underwent the procedure. The median duration from the start of chemotherapy to transplantation was 8.5 months. The median number of cycles before ASCT was 8. Of these, six were VPd, and the rest, Vd. No interference with stem cell mobilization was seen, and none of the patients required a second harvest procedure. The median duration for neutrophil and platelet engraftment was comparable to that for other regimens.

 Progression-free survival and overall survival were calculated as 67.7% and 70.7%, respectively, which is significantly low compared to MM survival rates in the current era. Overall, this study infers that the pomalidomide-based (VPd) regimen for NDMM was safe and efficacious. Further, the need for phase III trials is emphasized to demonstrate the survival benefits of this therapy for NDMM.

Source

Saj, F., Nisha, Y., Ganesan, P., Kayal, S., Kar, R., Halanaik, D., & Dubashi, B. (2023). Efficacy and safety of pomalidomide, bortezomib, and dexamethasone combination chemotherapy for newly diagnosed multiple myeloma: POMACE Phase II Study. Blood Cancer Journal, 13(1), 45. https://doi.org/10.1038/s41408-023-00816-8

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