Last reviewed · How we verify
NCT05284591: MYLENE
Non-interventional Study to Evaluate Patient and Healthcare Provider Satisfaction of Daratumumab Use in the Treatment of First-line Daratumumab, Lenalidomide, Dexamethasone (DRd) Multiple Myeloma Patients in Germany Depending on Application Route (sc or iv)
trial testing Daratumumab in Multiple Myeloma in 96 participants. Completed in 20 September 2024.
20 September 2024
Quick facts
| Lead sponsor | iOMEDICO AG |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 96 |
| Start date | 6 July 2022 |
| Primary completion | 20 September 2024 |
| Estimated completion | 20 September 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- Daratumumab (daratumumab) — full drug profile →
Conditions studied
- Multiple Myeloma — all drugs for Multiple Myeloma →
- Newly Diagnosed — all drugs for Newly Diagnosed →
- Transplant Ineligible — all drugs for Transplant Ineligible →
- Patient Satisfaction — all drugs for Patient Satisfaction →
Sponsor
iOMEDICO AG — full company profile →
Who can join
18 and older, any sex, with Multiple Myeloma or Newly Diagnosed. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
MYLENE is a prospective, multicenter, NIS to evaluate the patient and HCP satisfaction of sc and iv application of daratumumab in routine clinical practice in Germany. Patients observed in this study will be transplant ineligible NDMM patients for which the physician foresees an anti-myeloma therapy using DRd regimen as per local label. 250 NDMM patients treated with DRd will be enrolled (excluding screening failures, i.e., enrolled patients not fulfilling selection criteria identified before treatment start will be replaced) within 12 months in a proportion of approximately 1/3 patients receiving daratumumab sc and 2/3 patients receiving daratumumab iv as per physician's decision.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05284591
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Daratumumab
Trials testing the same drug.
- NCT07513129 — A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients · Phase 1 · not yet recruiting
- NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk · Phase 2, PHASE3 · not yet recruiting
- NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
- NCT07393282 — A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM) · Phase 3 · not yet recruiting
- NCT07391657 — A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regi · Phase 3 · recruiting
Other recruiting trials for Multiple Myeloma
Currently open trials in the same condition.
- NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
- NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
- NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
- NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
- NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting
Other iOMEDICO AG trials
Trials by the same sponsor.
- NCT06619275 — Ripretinib (QINLOCK®) According to Current SmPC · completed
- NCT06181734 — Ivosidenib (TIBSOVO®) Combined With Azacitidine According to Current SmPC · completed
- NCT05954780 — Selinexor (Nexpovio®) (SVd) in Patients With Relapsed or Refractory Multiple Myeloma · active not recruiting
- NCT05517265 — Acalabrutinib in Patients With Chronic Lymphocytic Leukemia With Direct Oral Anticoagulation (CICERO) · active not recruiting
- NCT05253911 — Tucatinib in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer Who Received at Least Two Prior An · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05284591 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by iOMEDICO AG
- Last refreshed: 1 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05284591.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing