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Clinical trial · no report yet · Phase 1
NCT02519452 trial: what clinicians have said so far
A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma
- NCT02519452 ↗
- Completed
- Janssen Research & Development, LLC
- Focused size, estimated: 1–150 verified statements
We haven't built an HCP commentary report on NCT02519452 (subcutaneous daratumumab in relapsed or refractory multiple myeloma) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on NCT02519452 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Indexed so far | |
|---|---|
| 3 posts on X |
The trial
ClinicalTrials.gov- Official title
- An Open-label, Multicenter, Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 1
- Status
- Completed
- Conditions
- Multiple Myeloma
- Interventions
- Daratumumab Subcutaneous (SC) Administration; Recombinant Human Hyaluronidase [rHuPH20]) SC Administration
- Arms
- Part 1: Cohort 1 · Experimental
- Part 1: Cohort 2 · Experimental
- Part 1: Cohort 3 · Experimental
- Part 2: Cohort 4 · Experimental
- Part 3: Dara-CF 1800 mg · Experimental
- Enrollment
- 120
- Primary outcomes
- Serum Trough Concentrations (Ctrough) of Daratumumab
- Part 1, 2 and 3: Number of Participants with Adverse Events (AEs) and Serious AEs
- Sponsor
- Janssen Research & Development, LLC
- Start
- Oct 22, 2015
- Primary completion
- Dec 13, 2017
- Results posted
- No
- Registry record
- NCT02519452 · updated May 23, 2025
Publications
linked from the registry- Li X, Dosne AG, Perez Ruixo C, Perez Ruixo JJ. Pharmacodynamic-Mediated Drug Disposition (PDMDD) Model of Daratumumab Monotherapy in Patients with Multiple Myeloma. Clin Pharmacokinet. 2023 May;62(5):761-777. doi: 10.1007/s40262-023-01232-8. Epub 2023 Apr 6. PubMed 37022569
- Nahi H, Usmani SZ, Mateos MV, van de Donk NWCJ, Oriol A, Plesner T, Bandyopadhyay N, Hellemans P, Tromp B, Nnane I, Zemlickis D, Chari A, Moreau P. Corticosteroid tapering is a safe approach in patients with relapsed or refractory multiple myeloma receiving subcutaneous daratumumab: part 3 of the open-label, multicenter, phase 1b PAVO study. Leuk Lymphoma. 2023 Feb;64(2):468-472. doi: 10.1080/10428194.2022.2148221. Epub 2023 Jan 2. No abstract available. PubMed 36593729
- Usmani SZ, Nahi H, Mateos MV, van de Donk NWCJ, Chari A, Kaufman JL, Moreau P, Oriol A, Plesner T, Benboubker L, Hellemans P, Masterson T, Clemens PL, Luo M, Liu K, San-Miguel J. Subcutaneous delivery of daratumumab in relapsed or refractory multiple myeloma. Blood. 2019 Aug 22;134(8):668-677. doi: 10.1182/blood.2019000667. Epub 2019 Jul 3. PubMed 31270103