Clinical trials: Daratumumab
Multiple Myeloma
A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects
Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity (Randomized, Double-blind, Parallel Controlled) of HLX15 with Daratumumab Injection in Healthy Chinese Male Subjects
- Trial name
- NCT05679258
- Testing
- HLX15, US-sourced DARZALEX®, CN-sourced DARZALEX®
- Where
- 2 sites in China
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Plasma Cell Myeloma
Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
Primary Objectives: Safety run-in Part: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) Randomized Phase 3 Part: To…
- Trial name
- NCT04270409
- Testing
- Isatuximab SAR650984, Lenalidomide, Dexamethasone
- Where
- 105 sites in United States, Australia and 22 more
- Volunteers
- 337 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subjects
The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-264 and Darzalex following a single intravenous infusion…
- Trial name
- NCT05974969
- Testing
- BCD-264, Darzalex
- Where
- 3 sites in Russia
- Volunteers
- 146 people, healthy volunteers welcome
- Sponsor
- Biocad
Multiple Myeloma
A Study to Compare the PK , Safety, and Immunogenicity of QL2109 With Daratumumab in Male Subjects
The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety and immunogenicity profiles of QL2109 and Darzalex following a single intravenous infusion in healthy male…
- Trial name
- NCT07400744
- Testing
- QL2109, Darzalex
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Multiple Myeloma, Light Chain Nephropathy
Novel Treatments in Improving Renal Outcomes in Light Chain Cast Nephropathy
Objective 1: To test whether treatment with plasma exchange improves renal recovery in patients with light chain cast nephropathy Objective 2: To compare renal outcomes among patients treated with plasma exchange versus…
- Conditions
- Multiple Myeloma, Light Chain Nephropathy, Acute Kidney Injury
- Trial name
- NCT06483139
- Testing
- Plasma exchange, Daratumumab
- Where
- United States
- Volunteers
- 549 people, healthy volunteers welcome
- Sponsor
- Brigham and Women's Hospital
Healthy
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants
The purpose of this study is to assess the safety and tolerability of daratumumab following a single subcutaneous (SC) administration in healthy participants and to determine whether premedication with corticosteroids is required…
- Trial name
- NCT03320707
- Testing
- Daratumumab, rHuPH20
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Tumor
A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults
The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL2109 with DARZALEX FASPRO® in healthy male volunteers.
- Trial name
- NCT06371534
- Testing
- QL2109, DARZALEX FASPRO®
- Where
- 2 sites in China
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hematological Malignancy
Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies
Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab).
- Trial name
- NCT01084252
- Testing
- Isatuximab SAR650984, Dexamethasone
- Where
- 59 sites in United States, Argentina and 15 more
- Volunteers
- 351 people, healthy volunteers welcome
- Sponsor
- Sanofi
High-risk Smoldering Multiple Myeloma, Multiple Myeloma
DARA RVD For High Risk SMM
The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and…
- Trial name
- PRISM (NCT04775550)
- Testing
- Daratumumab, Bortezomib, Lenalidomide
- Where
- 6 sites in United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Omar Nadeem, MD