ArticleHaematologica2021
Subcutaneous daratumumab in patients with relapsed or refractory multiple myeloma: Part 2 of the open-label, multicenter, dose-escalation phase 1b study (PAVO).
Article in Haematologica, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05849610 (An Open Label, Multicenter, Phase 2, Pilot Study, Evaluating Early Treatment With Bispecific T-cell Redirectors), which is not on this map. Cited by 19 papers.
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.
An Open Label, Multicenter, Phase 2, Pilot Study, Evaluating Early Treatment With Bispecific T-cell Redirectors (Teclistamab and Talquetamab) in the Frontline Therapy of Newly Diagnosed High-risk Multiple Myeloma
Who cites it
19 citing papers in PubMed, 34 citations in OpenAlex.
- Review
- Transitioning Therapeutic Antibodies in Oncology from Intravenous to Hyaluronidase-Facilitated Subcutaneous Administration.Clinical pharmacokinetics · 2026Review
- Post-dose observation after subcutaneous daratumumab: A service evaluation of safety and capacity impact.British journal of haematology · 2026Article
- Subcutaneous daratumumab in Chinese patients with relapsed or refractory multiple myeloma: an open-label, multicenter, phase 1 study (MMY1010).Blood science (Baltimore, Md.) · 2024Article
- Daratumumab Treatment for "Truly Frail" Elderly Myeloma Patients.Life (Basel, Switzerland) · 2024Review
- Clinical Pharmacokinetics and Pharmacodynamics of Daratumumab.Clinical pharmacokinetics · 2023Review
- Review
- Daratumumab, carfilzomib, and dexamethasone in relapsed or refractory myeloma: final analysis of PLEIADES and EQUULEUS.Blood cancer journal · 2023Article
- Benefits of switching from intravenous to subcutaneous daratumumab: Perspectives from UK healthcare providers.Frontiers in oncology · 2023Article
- Risk Factors, Hyaluronidase Expression, and Clinical Immunogenicity of Recombinant Human Hyaluronidase PH20, an Enzyme Enabling Subcutaneous Drug Administration.The AAPS journal · 2022Article
- Exposure-Response and Population Pharmacokinetic Analyses of a Novel Subcutaneous Formulation of Daratumumab Administered to Multiple Myeloma Patients.Journal of clinical pharmacology · 2021Article
- Practical Considerations for the Daratumumab Management in Portuguese Routine Clinical Practice: Recommendations From an Expert Panel of Hematologists.Frontiers in oncology · 2021Article
- Results of a Time and Motion Survey Regarding Subcutaneous versus Intravenous Administration of Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma.ClinicoEconomics and outcomes research : CEOR · 2021Article
- Subcutaneous delivery of daratumumab in Japanese patients with relapsed/refractory multiple myeloma.International journal of hematology · 2021Article
- Should all newly diagnosed MM patients receive CD38 antibody-based treatment?Hematology. American Society of Hematology. Education Program · 2020Review
- Monoclonal Antibodies: Leading Actors in the Relapsed/Refractory Multiple Myeloma Treatment.Pharmaceuticals (Basel, Switzerland) · 2020Review
- Evaluating Daratumumab in the Treatment of Multiple Myeloma: Safety, Efficacy and Place in Therapy.Cancer management and research · 2020Review
- Novel Approaches for the Management of AL Amyloidosis.Current hematologic malignancy reports · 2018Review
- AL Amyloidosis: Unfolding a Complex Disease.Journal of the advanced practitioner in oncologyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 14 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Intravenous daratumumab is approved for the treatment of multiple myeloma. In Part 1 of the PAVO study, a mix-and-deliver subcutaneous formulation of daratumumab with recombinant human hyaluronidase PH20 (rHuPH20) was well tolerated, with low rates of infusion-related reactions and similar efficacy to intravenous daratumumab. Part 2 of PAVO evaluated a concentrated, pre-mixed co-formulation of daratumumab and rHuPH20 (DARA SC). Patients with ≥2 prior lines of therapy, including a proteasome inhibitor and immunomodulatory drug, received daratumumab (1800 mg) and rHuPH20 (30,000 U) in 15 mL subcutaneously over 3-5 minutes per the approved intravenous monotherapy dosing schedule. Primary endpoints were daratumumab trough concentration at the end of weekly dosing (just prior to the Cycle 3 Day 1 dose) and safety. Twenty-five patients were enrolled in PAVO Part 2. DARA SC achieved daratumumab trough concentrations similar to or greater than intravenous daratumumab 16 mg/kg. The adverse event profile of DARA SC was consistent with intravenous daratumumab, with no new safety concerns and a lower infusion-related reaction rate. At a median follow-up of 14.2 months, the overall response rate was 52%, median duration of response was 15.7 months, and median progression-free survival was 12.0 months. DARA SC 1800 mg was well tolerated in relapsed/refractory multiple myeloma, with a low infusion-related reaction rate and reduced administration time. Daratumumab serum concentrations following DARA SC were consistent with intravenous dosing, and deep and durable responses were observed. Based on these results, ongoing studies are investigating DARA SC in multiple myeloma and other conditions. (ClinicalTrials.gov identifier: 02519452).
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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.