What are the dose and schedule of Ninlaro + Revlimid + dexamethasone?

refractory myeloma. Progression-free survival (PFS) benefit with Ninlaro-Rd versus placebo-Rd did not translate into a statistically significant OS benefit on intent-to-treat analysis. OS benefit was greater in subgroups with adverse prognostic factors. OS interpretation was confounded by imbalances in subsequent therapies received. In July 2021, the journal Blood published a report by Dr. Thierry Facon and colleagues with the results of the large randomized TOURMALINE-MM2 clinical trial including 705 transplantation-ineligible patients with newly diagnosed myeloma. Data show that the addition of Ninlaro to the standardtreatment Rd doublet results in a clinically meaningful PFS benefit, although it did not reach statistical significance. It has already been shown that triplets including a proteasome inhibitor and an immunomodulator significantly improve PFS in myeloma, both in relapsed disease and in newly diagnosed patients, both in transplant-eligible and transplant-ineligible patients. Therefore, the standard of care at this time is the combination of Velcade® (bortezomib) plus Rd (VRd). However, the high incidence of Velcade-induced peripheral neuropathy often prevents long-term administration, so evaluating the efficacy and safety of the other FDA-approved proteasome inhibitors, Ninlaro and Kyprolis® (carfilzomib), is important. Ninlaro is less neurotoxic than Velcade and less cardiotoxic that Kyprolis, and Ninlaro is administered orally. The combination of Ninlaro-Rd might be an attractive alternative to VRd, especially in older patients. Ninlaro is being studied in clinical trials in a wide spectrum of combination therapies and across disease settings. Contact the IMF InfoLine or visit clinicaltrials.gov for up-to-date information.

Ninlaro is taken in 4-week (28-day) cycles. The recommended starting dose of Ninlaro is one 4 mg capsule taken orally on Days 1, 8, and 15 of a 28-day treatment cycle. Thus, one capsule of Ninlaro is taken once a week for the first three weeks of every 4-week (28-day) cycle. No Ninlaro is taken during the fourth week of each cycle. Ninlaro also comes in 3 mg and 2.3 mg capsules, and your doctor can reduce the dose of Ninlaro depending upon your medical status and side effects. If you have moderate or severe liver or kidney dysfunction at the time you start treatment with Ninlaro, your dose of Ninlaro should be lowered. The starting dose for patients with moderate to severe liver or kidney impairment is 3 mg. For patients with kidney disease requiring dialysis, Ninlaro is not dialyzable and therefore can be administered without regard to the timing of dialysis. The recommended starting dose of Revlimid is 25 mg taken orally on Days 1 through 21 of a 28-day treatment cycle.