Triple drug regimens are standard of care in newly diagnosed Multiple Myeloma (MM). Studies show 4 drug regimens to be highly active. In an economically backward country like India, newer drugs and Autologous transplant may not always be feasible because of financial constraints. We studied the effect of adding Pegylated Liposomal Doxorubicin (PLD) to standard regimen on the Response Rates (RR).
60 newly diagnosed cases of MM were included in this double armed prospective, observational, comparative study. Patients were randomly assigned into 2 arms (30 Patients in each arm). Arm A consisted of VTd regimen (Inj. Bortezomib Day (D)1, D8, D15, D22 1.3mg/ / m2, Tab. Thalidomide Daily 100mg, Inj. Dexamethasone D1, D8, D15, D22 40 mg / once in 28 days). Arm B consisted of VTdD regimen (PLD D1 i.v 30mg / m2 + VTd). Hematological and biochemical parameters were noted at baseline and after completion of 4 cycles. Response assessment was done as per the criteria defined by International Myeloma Working Group (IMWG). The outcomes between the two treatment arms in terms of RR were compared.
|Overall Response Rates||86.6%||93.3%|
|>very good partial response||73.3%||86.6%|
|Stringent Complete Response||33.3%||53.3%|
The differences in sCR rates were clinically very significant. However, on application of Pearson chi-square test significance p of 0.118 was seen, which maybe attributed to the lower power of the study. Poorest responses noted were highest in the 71-80 age group. Both the regimens were equally effective in ISS B patients. Neutropenia, thrombocytopenia, infections, mucositis, edema, dizzininess/somnolence and DVT were not significantly different between the two arms (P > 0.05). Palmar–plantar erythrodysesthesia (PPE) was the only new complication seen in (10%) VTdD group. Grade 3–4 toxicities were similar in both arms.
The role of liposomal doxorubicin in first line setting as a 4th agent along with triple drug regimen in treatment of MM looks promising, especially in countries with financial constraints for the newer drugs. Larger studies are needed to validate this.
Clinical trial identification
Legal entity responsible for the study
Scientific and Ethics Committee at HCG Hospital, Bangalore, India.
Has not received any funding.
All authors have declared no conflicts of interest.