Related Experiment Video
Updated: Apr 5, 2026
Analyzing Tumor and Tissue Distribution of Target Antigen Specific Therapeutic Antibody
Published on: May 16, 2020
Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma
Henk M Lokhorst1, Torben Plesner, Jacob P Laubach
1From the Department of Hematology, University Medical Center Utrecht, Utrecht (H.M.L., M.C.M., N.W.C.J.D.), and the Department of Hematology, VU University Medical Center, Amsterdam (H.M.L., N.W.C.J.D.) - both in the Netherlands; Vejle Hospital and University of Southern Denmark, Vejle (T.P., J.K.), and Rigshospitalet and University of Copenhagen (P.G., U.L.) and Genmab (N.L., S.L., L.B., N.B.), Copenhagen - all in Denmark; Dana-Farber Cancer Institute, Harvard Medical School, Boston (J.P.L., P.G.R.); Karolinska Institute and the Department of Medicine, Division of Hematology, Karolinska University Hospital at Huddinge, Stockholm (H.N.), and Skåne University Hospital and Lund University, Lund (M.H.) - all in Sweden; Myeloma Unit, Division of Hematology, University of Turin, Turin, Italy (A.P.); Janssen Research and Development, Spring House, PA (T.A., C.M.U., A.K.S.); and Janssen Research and Development, Raritan, NJ (I.K., J.W.).
Daratumumab, a CD38-targeting antibody, showed a favorable safety profile and encouraging efficacy in patients with relapsed or refractory multiple myeloma. This study provides evidence for its potential in heavily pretreated patients.
Area of Science:
- Oncology
- Immunology
Background:
- Multiple myeloma cells overexpress CD38.
- Daratumumab is a CD38-targeting human IgG1κ monoclonal antibody.
Purpose of the Study:
- To evaluate the safety and efficacy of daratumumab in patients with relapsed or refractory multiple myeloma.
Main Methods:
- Phase 1-2 trial with dose-escalation (Part 1) and dose-expansion (Part 2).
- Part 2 involved 72 patients receiving daratumumab at 8 mg/kg or 16 mg/kg weekly, bi-monthly, or monthly.
- Endpoints included safety, efficacy, and pharmacokinetics.
Main Results:
- No maximum tolerated dose identified.
- Overall response rate was 36% at 16 mg/kg and 10% at 8 mg/kg.
- Median progression-free survival was 5.6 months at 16 mg/kg; 65% of responders did not progress at 12 months.
- Mild infusion reactions (71% any grade, 1% grade 3); common grade 3/4 adverse events included pneumonia and thrombocytopenia.
Conclusions:
- Daratumumab monotherapy demonstrates a favorable safety profile.
- Encouraging efficacy observed in heavily pretreated and refractory multiple myeloma patients.
- Supports daratumumab as a potential treatment option for this patient population.
![Dynamic Imaging of Chimeric Antigen Receptor T Cells with [18F]Tetrafluoroborate Positron Emission Tomography/Computed Tomography](/_next/image?url=https%3A%2F%2Fcloudfront.jove.com%2FCDNSource%2Fteasers%2F62334.jpg&w=3840&q=50)
