Using the recommended dose of 1.3 mg/m2administered as a 3- to 5-second bolus intravenous (IV) injection on days 1, 4, 8, and 11 of 21-day cycles, patients with relapsed multiple myeloma (MM) after 1 to 3 previous lines of therapy achieved noninferior efficacy with subcutaneous versus IV delivery of the drug when receiving up to eight 21-day cycles. In addition, those in the SQ arm experienced improvement in their systemic safety profile.
In a phase 3 randomized trial, Moreau and colleagues found an overall response rate (ORR) of 42% after 4 cycles (ORR difference –0.4%; 95% confidence interval [CI], –14.3 to 13.5; P =.002). At 12 months, they found no significant differences in time to progression (median 10.4 months; 95% CI, 8.5-11.7 vs 9.4 months; 95% CI, 7.6-10.6; P = .387) and 1-year overall survival (72.6%; 95% CI, 63.1-80.0 vs 76.7%; 95% CI, 64.1-85.4; P = .504) with SQ versus IV administration. Noninferiority was defined as retaining 60% of the IV treatment effect.
In the SQ group, adverse events, grade 3 or higher included thrombocytopenia (13%), neutropenia (18%), and anemia (12%). Less peripheral neuropathy of any grade was experience in the SQ arm compared with the IV arm (38% vs 53%; P = .044), grade 2 or worse (24% vs 41%, respectively; P = .012), and grade 3 or worse (6% vs 16%, respectively; P = .026).
The researchers concluded that “subcutaneous administration is a promising alternative to intravenous administration, particularly in patients with poor venous access or at increased risk of side-effects.”
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