Trial reportBlood2016
Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma.
Trial report in Blood, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07021677 (Daratumumab for Minimal Residual Disease Eradication in T-Acute Lymphoblastic Leukemia - A Phase 2 Study), which is not on this map. Cited by 197 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Daratumumab for Minimal Residual Disease Eradication in T-Acute Lymphoblastic Leukemia - A Phase 2 Study
Who cites it
197 citing papers in PubMed, 3 syntheses or guidelines pooled it, 403 citations in OpenAlex.
- Optimizing oncology drug development: systematic review of 22 years of myeloma randomized controlled trials.Journal of the National Cancer Institute · 2026Pooled it
- Outcomes in patients with relapsed/refractory multiple myeloma with extramedullary disease: a meta-analysis.Annals of hematology · 2025Pooled it
- Infection risks associated with daratumumab-containing regimens in multiple myeloma: a systematic review and meta-analysis.Frontiers in oncology · 2025Pooled it
- Efficacy and safety of melflufen plus daratumumab and dexamethasone in relapsed/refractory multiple myeloma: results from the randomized, open-label, phase III LIGHTHOUSE study.Haematologica · 2024Trial
- Comparative Efficacy of Teclistamab Versus Current Treatments in Real-World Clinical Practice in the Prospective LocoMMotion Study in Patients with Triple-Class-Exposed Relapsed and/or Refractory Multiple Myeloma.Advances in therapy · 2023Trial
- Phase II trial of daratumumab with DCEP in relapsed/refractory multiple myeloma patients with extramedullary disease.Journal of hematology & oncology · 2022Trial
- Efficacy and safety of daratumumab combined with all-trans retinoic acid in relapsed/refractory multiple myeloma.Blood advances · 2021Trial
- KarMMa-RW: comparison of idecabtagene vicleucel with real-world outcomes in relapsed and refractory multiple myeloma.Blood cancer journal · 2021Trial
- Melflufen and Dexamethasone in Heavily Pretreated Relapsed and Refractory Multiple Myeloma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Trial
- Isatuximab monotherapy in relapsed/refractory multiple myeloma: A Japanese, multicenter, phase 1/2, safety and efficacy study.Cancer science · 2020Trial
- Trial
- Nelfinavir and lenalidomide/dexamethasone in patients with lenalidomide-refractory multiple myeloma. A phase I/II Trial (SAKK 39/10).Blood cancer journal · 2019Trial
- Trial
- Infectious complications and NK cell depletion following daratumumab treatment of Multiple Myeloma.PloS one · 2019Trial
- Trial
- Trial
- Phase 1/2 study of daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma.Blood · 2016Trial
- Daratumumab in patients with immune thrombocytopenia: a single-center, open-label, phase 2 trial.EClinicalMedicine · 2026Article
- Extramedullary Disease-Achilles Heel in Myeloma?American journal of hematology · 2026Review
- Immunologic Combinations in Multiple Myeloma: Synergistic Stimulation with T cells and NK cells.International journal of biological sciences · 2026Review
137 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 11 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The efficacy and favorable safety profile of daratumumab monotherapy in multiple myeloma (MM) was previously reported. Here, we present an updated pooled analysis of 148 patients treated with daratumumab 16 mg/kg. Data were combined from part 2 of a first-in-human phase 1/2 study of patients who relapsed after or were refractory to ≥2 prior therapies and a phase 2 study of patients previously treated with ≥3 prior lines of therapy (including a proteasome inhibitor [PI] and an immunomodulatory drug [IMiD]) or were double refractory. Among the pooled population, patients received a median of 5 prior lines of therapy (range, 2 to 14 prior lines of therapy), and 86.5% were double refractory to a PI and an IMiD. Overall response rate was 31.1%, including 13 very good partial responses, 4 complete responses, and 3 stringent complete responses. The median duration of response was 7.6 months (95% confidence interval [CI], 5.6 to not evaluable [NE]). The median progression-free survival (PFS) and overall survival (OS) were 4.0 months (95% CI, 2.8-5.6 months) and 20.1 months (95% CI, 16.6 months to NE), respectively. When stratified by responders vs stable disease/minimal response vs progressive disease/NE, median PFS was 15.0 months (95% CI, 7.4 months to NE) vs 3.0 months (95% CI, 2.8-3.7 months) vs 0.9 months (95% CI, 0.9-1.0 months), respectively, and median OS was NE (95% CI, NE to NE) vs 18.5 months (95% CI, 15.1-22.4 months) vs 3.7 months (95% CI, 1.7-7.6 months), respectively. No new safety signals were identified. In this pooled data set, daratumumab 16 mg/kg monotherapy demonstrated rapid, deep, and durable responses, with a clinical benefit that extended to patients with stable disease or better.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.