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Early Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated
Meral Beksac1, Yildiz Aydin2, Hakan Goker3
1Department of Hematology, Ankara University Faculty of Medicine, Ankara, Turkey.
Background:
In countries where frontline drug approval is limited to first-generation proteasome inhibitors or immunomodulatory drugs, relapses have been both more frequent and less durable. We investigated real world data on the efficacy and safety of daratumumab monotherapy among patients with relapsed refractory multiple myeloma (RRMM) from Turkey using a prospective early access program.
Patients And Methods:
A total of 42 patients with RRMM after a minimum of 3 previous lines of proteasome inhibitor/immunomodulatory drug-based treatments were included from 25 centers across Turkey. Daratumumab monotherapy was administered intravenously at a dose of 16 mg/kg weekly (cycles 1-2), on alternate weeks (cycles 3-6), and monthly thereafter.
Results:
The median daratumumab monotherapy duration was 5.5 months (range, 0.2-28.7 months). The overall response rate was 45.2%, including 14 (33.3%) partial responses, 4 (9.5%) very good partial responses, and 1 (2.4%) complete response. The median duration of response was 4.9 months. The median progression-free survival (PFS) was 5.5 (95% confidence interval, 2.6-8.4 months) with 12- and 18-month PFS rates of 35.7% and 31.0%, respectively. The median overall survival was not reached; the 12- and 18-month overall survival rates were 64.3% and 59.5%, respectively. The depth of response had a significant effect on PFS (log-rank test, P = .026). Overall, of the 76 adverse events reported, 33 (43.4%) were grade ≥ 3; only 4 (9.52%) were grade 3 infusion-related reactions. No infusion-related reactions or adverse events led to treatment discontinuation.
Conclusion:
The present findings from our daratumumab early access program have confirmed the efficacy and safety profile of daratumumab monotherapy in heavily pretreated Turkish patients with RRMM.
Insights
Daratumumab monotherapy shows efficacy in Turkish patients with relapsed refractory multiple myeloma (RRMM) who have undergone prior treatments. This study confirms its safety and effectiveness in a real-world setting.
Area of Science:
- Oncology
- Hematology
- Clinical Pharmacology
Background:
- Relapsed refractory multiple myeloma (RRMM) presents challenges with limited treatment options.
- First-generation proteasome inhibitors or immunomodulatory drugs may lead to frequent and less durable relapses.
Purpose of the Study:
- To evaluate the real-world efficacy and safety of daratumumab monotherapy.
- To assess outcomes in heavily pretreated Turkish patients with RRMM.
Main Methods:
- A prospective early access program in Turkey included 42 RRMM patients.
- Patients received daratumumab monotherapy intravenously after at least 3 prior treatment lines.
Main Results:
- Overall response rate was 45.2%, with a median progression-free survival (PFS) of 5.5 months.
- Median overall survival was not reached; 18-month OS rate was 59.5%.
- Adverse events were manageable, with no treatment discontinuations due to infusion reactions.
Conclusions:
- Daratumumab monotherapy demonstrated efficacy and a favorable safety profile in Turkish RRMM patients.
- Findings support daratumumab's role in heavily pretreated RRMM patients within this population.