Trial reportHaematologica2022
Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma.
Trial report in Haematologica, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03277105 (A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma), which is not on this map. Cited by 31 papers, 2 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.
A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma
Who cites it
31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.
- Effect of daratumumab on patients with high-risk cytogenetic multiple myeloma: a systematic review and meta-analysis of randomized controlled trials.Frontiers in immunology · 2026Pooled it
- Differences Between Intravenous and Subcutaneous Modes of Administration in Oncology from the Patient, Healthcare Provider, and Healthcare System Perspectives: A Systematic Review.Advances in therapy · 2024Pooled 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
- Review
- Retrospective study of infusion-related reactions in subcutaneous daratumumab administration in Japan.Experimental and therapeutic medicine · 2026Article
- Post-dose observation after subcutaneous daratumumab: A service evaluation of safety and capacity impact.British journal of haematology · 2026Article
- Potential Mechanisms of Partial/Transient Response or Resistance to Daratumumab Therapy: A Focus on Anti-Daratumumab Antibodies and Urinary Daratumumab Loss.Antibodies (Basel, Switzerland) · 2026Review
- A phase I study evaluating subcutaneous administration of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced solid malignancies.Cancer immunology, immunotherapy : CII · 2026Article
- Feasibility assessment of an EHR-integrated research platform for prospective data collection in community oncology practice.npj health systems · 2026Article
- Efficacy and safety of daratumumab-based quadruplet therapy vs non-daratumumab-based triplet therapy in newly diagnosed multiple myeloma patients: A GRADE assessed systematic review and meta-analysis of randomized controlled trials.Therapeutic advances in hematology · 2026Article
- Anti-CD38 monoclonal antibodies in multiple myeloma and beyond: immunotherapeutic mechanisms, evidence maturity, and clinical positioning.Frontiers in immunology · 2026Review
- Evaluating nurse preferences for a novel on-body delivery system vs. manual syringes for large-volume subcutaneous drug administration: a survey study.Drug delivery · 2025Article
- Daratumumab-Based Combinational Therapy as Second-Line Treatment of Relapsed-Refractory Multiple Myeloma: A Single-Center Experience.Cancer reports (Hoboken, N.J.) · 2025Observational
- The Safety, Tolerability, and Pharmacokinetics of ALT-BB4 (A Novel Recombinant Hyaluronidase): A Randomized, Double-Blinded, Placebo-Controlled, Phase 1 Study in Healthy Volunteers.Dermatology and therapy · 2025Article
- Phase 2 trial of daratumumab, cyclophosphamide, thalidomide, and dexamethasone in newly diagnosed multiple myeloma.Blood neoplasia · 2025Article
- Predictive and Prognostic Significance of Patient-Reported Outcomes for Survival and Adverse Events in Daratumumab-Treated Multiple Myeloma.European journal of haematology · 2025Article
- Real-world data on the use of subcutaneous daratumumab plus bortezomib, thalidomide, and dexamethasone in transplant-eligible patients with newly diagnosed multiple myeloma.Annals of hematology · 2025Observational
- Review
- Daratumumab Versus Control Treatment: A Systematic Review and Meta-analysis Study of Survival Outcomes Among Multiple Myeloma Patients : Survival Outcomes of Multiple Myeloma Treatment with Daratumumab.Galen medical journal · 2025Review
- Cost of Anti-CD38 Monoclonal Antibodies in Combination With Bortezomib, Lenalidomide and Dexamethasone for the Frontline Treatment of Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma in the US.Journal of health economics and outcomes research · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
28 authors at 20 institutions in 14 countries.
Funding
Abstract
In the primary analysis of the phase III COLUMBA study, daratumumab by subcutaneous administration (DARA SC) demonstrated non-inferiority to intravenous administration (DARA IV) for relapsed or refractory multiple myeloma (RRMM). Here, we report the final analysis of efficacy and safety from COLUMBA after a median of 29.3 months follow-up (additional 21.8 months after the primary analysis). In total, 522 patients were randomized (DARA SC, n=263; DARA IV, n=259). With longer follow-up, DARA SC and DARA IV continued to show consistent efficacy and maximum trough daratumumab concentration as compared with the primary analysis. The overall response rate was 43.7% for DARA SC and 39.8% for DARA IV. The maximum mean (standard deviation [SD]) trough concentration (cycle 3, day 1 pre-dose) of serum DARA was 581 (SD, 315) μg/mL for DARA SC and 496 (SD, 231) μg/mL for DARA IV. Median progression-free survival was 5.6 months for DARA SC and 6.1 months for DARA IV; median overall survival was 28.2 months and 25.6 months, respectively. Grade 3/4 treatment-emergent adverse events occurred in 50.8% of patients in the DARA SC group and 52.7% in the DARA IV group; the most common (≥10%) were thrombocytopenia (DARA SC, 14.2%; DARA IV, 13.6%), anemia (13.8%; 15.1%), and neutropenia (13.1%; 7.8%). The safety profile remained consistent with the primary analysis after longer follow-up. In summary, DARA SC and DARA IV continue to demonstrate similar efficacy and safety, with a low rate of infusion-related reactions (12.7% vs. 34.5%, respectively) and shorter administration time (3-5 minutes vs. 3-7 hours) supporting DARA SC as a preferable therapeutic choice. (Clinicaltrials gov. Identifier: NCT03277105.
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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.