Lenalidomide, bortezomib. and dexamethasone (RVD) is considered a new standard-of- care regimen for patients with newly diagnosed multiple myeloma. A previous phase 1/2 study of RVD in frontline myeloma showed good efficacy, but high rates of peripheral neuropathy (PN).1 Subcutaneous (SQ) administration of single-agent bortezomib has demonstrated non-inferiority to intravenous bortezomib and led to lower rates of PN.2
In the Lenalidomide, Subcutaneous Bortezomib and Dexamethasone (RsqVD) study, a multicenter, open-label, single-arm phase 2 trial, eligible patients received SQ bortezomib with lenalidomide and dexamethasone. All patients subsequently received maintenance therapy with lenalidomide until progression, plus the addition of SQ bortezomib twice monthly in high-risk patients. The primary end point was overall response rate (ORR) after 4 cycles of induction therapy.
Patients were treated with 4 cycles of lenalidomide 25 mg/day on days 1-14 and dexamethasone 20 mg/day on days 1, 2, 4, 5, 8, 9, 11, and 12 plus bortezomib 1.3 mg/m2 as SQ injection on days 1, 4, 8, and 11 of a 21-day cycle. After 4 cycles, patients were scheduled to proceed with autologous stem-cell transplant (ASCT) or further induction therapy up to a total of 8 cycles. Following completion of ASCT or induction therapy, all patients were scheduled to receive lenalidomide maintenance until progression, unacceptable toxicity, or withdrawal of consent.
In terms of results, the median number of induction cycles completed was 4 (1-8 cycles). A total of 40 of 42 patients were considered evaluable for the primary end point of ORR. A preliminary analysis of ORR following 4 cycles of induction therapy indicates that 92.5% (37/40) of patients achieved partial response or better. PN of any grade has been reported in 50% of patients; no grade 4 PN was reported.
Researchers concluded that RsqVD showed comparable efficacy to the RVD treatment regimen in patients with newly diagnosed multiple myeloma, with better tolerability when compared with the RVD treatment regimen incorporating IV bortezomib.
O’Gorman P, et al. ASH 2016. Abstract 2117.
- Richardson, et al. Blood. 2010.
- Moreau, et al. Lancet Oncol. 2011.