Trial reportJournal of cancer research and clinical oncology2021
Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results.
Trial report in Journal of cancer research and clinical oncology, 2021. 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 13 papers, 1 of them a synthesis that pooled it.
What it found
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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
13 citing papers in PubMed, 1 synthesis or guideline pooled 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
- Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma.Haematologica · 2022Trial
- A multicenter, phase Ib study of subcutaneous administration of isatuximab in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.Haematologica · 2024Article
- The Role of Patient-Reported Outcomes to Measure Treatment Satisfaction in Drug Development.The patient · 2024Article
- Description of Feelings, Perception, and Experience Before and After Switching from IV Daratumumab to the SC Form: A Mixed-Method, Cross-Sectional Survey in Multiple Myeloma Patients in Europe.Patient preference and adherence · 2024Article
- Improved efficiency of daratumumab treatment of multiple myeloma adopting the subcutaneous route: A micro-costing analysis in three Italian hematology centers.Cancer medicine · 2023Article
- Real-world Duration of Use and Dosing Frequency of Daratumumab in Patients With Multiple Myeloma in the United States.Mayo Clinic proceedings. Innovations, quality & outcomes · 2023Article
- Clinical Administration Characteristics of Subcutaneous and Intravenous Administration of Daratumumab in Patients With Multiple Myeloma at Mayo Clinic Infusion Centers.JCO oncology practice · 2023Article
- Review
- Benefits of switching from intravenous to subcutaneous daratumumab: Perspectives from UK healthcare providers.Frontiers in oncology · 2023Article
- Toxicity management strategies for next-generation novel therapeutics in multiple myeloma.Therapeutic advances in hematology · 2022Review
- [Reflections on the innovative research and development of hematologic oncology drugs under the new situation].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2021Article
- Immunotherapy of Multiple Myeloma: Promise and Challenges.ImmunoTargets and therapy · 2021Review
Corrections and comments
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe phase III COLUMBA study evaluated daratumumab (DARA) intravenous (IV) and subcutaneous (SC) in patients with relapsed or refractory multiple myeloma. Here, we report patient-reported satisfaction with therapy (SWT) in COLUMBA.
methodsDARA IV or DARA SC was administered weekly (cycles 1-2), every 2 weeks (cycles 3-6), and every 4 weeks (cycles 7 +). Patients completed a modified version of the Cancer Therapy Satisfaction Questionnaire (CTSQ) at weekly (cycles 1-2) and monthly (cycles 3 +) intervals and at the end of treatment. Results for each item and the SWT domain score were summarized using descriptive statistics. The distribution of responses for individual items was calculated for each assessment. The proportion of patients for whom SWT domain score change from first assessment met or exceeded the minimally important difference (MID) of 5.9 points was calculated at each assessment time point.
resultsTwo-hundred fifty-nine patients were randomized to DARA IV and 263 to DARA SC. Mean scores for SWT domain questions were high and largely positive during treatment. Responses indicating positive perceptions of therapy were given by a numerically greater proportion of patients in the DARA SC group than the DARA IV group for most questions. Changes from the first assessment in SWT domain scores met or exceeded the MID for an average of ~ 40% of patients.
conclusionIn COLUMBA, modified CTSQ results suggest patients in the DARA SC group were more satisfied with their cancer therapy than those in the DARA IV group.
trial registrationClinicalTrials.gov identifier NCT03277105. Registered September 8, 2107.
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