Clinical trial · Interventional
Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma
Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma - Open Label, Dose-escalation Followed by Open Label, Single-arm Study
NCT00574288CI-TRIAL-00032705completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Establishment of safety profile of HuMax-CD38 when given as monotherapy in participants with multiple myeloma relapsed from or refractory to at least 2 different cytoreductive therapies and without further established treatment options.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Other | — | UNRESOLVED |
| Methylprednisolone | Other | — | UNRESOLVED |
| Part 1: Daratumumab | Drug | — | UNRESOLVED |
| Part 2: Daratumumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation: Daratumumab
- interventionNames
- Drug: Part 1: Daratumumab
- Other: Methylprednisolone
- type
- EXPERIMENTAL
- label
- Dose Expansion: Daratumumab
- interventionNames
- Drug: Part 2: Daratumumab
- Other: Methylprednisolone
- Other: Dexamethasone
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- Up to Week 28 (for Part 1) and up to approximately 2.5 years (for Part 2)
- description
- An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * Diagnosis of multiple myeloma (MM) requiring systemic therapy * Age greater than or equal to (\>=) 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Life expectancy greater than (\>) 3 months * Relapsed from or refractory to two or more different prior therapies * Signed Informed consent Exclusion criteria * Plasma cell leukemia defined as a plasma cell count \> 2000/millimeter\^3 (mm\^3) * Known amyloidosis * Participants who previously have received an allogeneic stem cell transplant * Sensory or motor neuropathy of \>= grade 3 * Past or current malignancy * Chronic or ongoing active infectious disease * Clinically significant cardiac disease * Significant concurrent, uncontrolled medical condition including, but not limited to, renal (except related to MM), hepatic, hematological except MM, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease * A baseline QT interval as corrected by Fridericia's formula \> 470 millisecond (msec) for female participants or \> 450 msec for male participants or a complete left bundle branch block (defined as a QRS interval \>= 120 msec in left bundle branch block form) * Hypokalemia * Clinical signs of meningeal involvement of MM * Known severe chronic obstructive pulmonary disease or asthma defined as forced expiratory volume in 1 second (FEV1) less than (\<) 60 percentage (%) of expected * History of significant cerebrovascular disease * Known Human Immunodeficiency Virus seropositivity * Positive serology for hepatitis B * Screening laboratory values * Concomitant corticosteroid * Other chemotherapy that is or may be active against myeloma within 3 weeks prior to Visit 2 (Part 1) or the first dose of daratumumab (Part 2). However, corticosteroid for myeloma (less than a 4-day course) could be administered within 1 week before Visit 2 (Part 1) or the first dose of daratumumab (Part 2) * Known hypersensitivity to components of the investigational product or severe allergic or anaphylactic reactions to humanized products * Participants who have received treatment with any nonmarket drug substance within 4 weeks before the first dose of daratumumab * Current participation in any other interventional clinical trial * Participants known or suspected of not being able to comply with a trial protocol (example, due to alcoholism, drug dependency, or psychological disorder) * Breastfeeding women or women with a positive pregnancy test at Screening * Women of childbearing potential not willing to use adequate contraception, defined as hormonal birth control or intrauterine device, during the trial and for 1 year after the last dose of daratumumab. For participants in the United States, the use of a double-barrier method is also considered adequate
References
Publications (6)
- DERIVEDLi 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. PMID 37022569
- DERIVEDUsmani SZ, Nahi H, Plesner T, Weiss BM, Bahlis NJ, Belch A, Voorhees PM, Laubach JP, van de Donk NWCJ, Ahmadi T, Uhlar CM, Wang J, Feng H, Qi M, Richardson PG, Lonial S. Daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma: final results from the phase 2 GEN501 and SIRIUS trials. Lancet Haematol. 2020 Jun;7(6):e447-e455. doi: 10.1016/S2352-3026(20)30081-8. PMID 32470437
- DERIVEDAdams HC 3rd, Stevenaert F, Krejcik J, Van der Borght K, Smets T, Bald J, Abraham Y, Ceulemans H, Chiu C, Vanhoof G, Usmani SZ, Plesner T, Lonial S, Nijhof I, Lokhorst HM, Mutis T, van de Donk NWCJ, Sasser AK, Casneuf T. High-Parameter Mass Cytometry Evaluation of Relapsed/Refractory Multiple Myeloma Patients Treated with Daratumumab Demonstrates Immune Modulation as a Novel Mechanism of Action. Cytometry A. 2019 Mar;95(3):279-289. doi: 10.1002/cyto.a.23693. Epub 2018 Dec 11. PMID 30536810
- DERIVEDKrejcik J, Frerichs KA, Nijhof IS, van Kessel B, van Velzen JF, Bloem AC, Broekmans MEC, Zweegman S, van Meerloo J, Musters RJP, Poddighe PJ, Groen RWJ, Chiu C, Plesner T, Lokhorst HM, Sasser AK, Mutis T, van de Donk NWCJ. Monocytes and Granulocytes Reduce CD38 Expression Levels on Myeloma Cells in Patients Treated with Daratumumab. Clin Cancer Res. 2017 Dec 15;23(24):7498-7511. doi: 10.1158/1078-0432.CCR-17-2027. Epub 2017 Oct 12. PMID 29025767
- DERIVEDNijhof IS, Casneuf T, van Velzen J, van Kessel B, Axel AE, Syed K, Groen RW, van Duin M, Sonneveld P, Minnema MC, Zweegman S, Chiu C, Bloem AC, Mutis T, Lokhorst HM, Sasser AK, van de Donk NW. CD38 expression and complement inhibitors affect response and resistance to daratumumab therapy in myeloma. Blood. 2016 Aug 18;128(7):959-70. doi: 10.1182/blood-2016-03-703439. Epub 2016 Jun 15. PMID 27307294