Actively Recruiting
A Randomized, Double-blind Study Comparing HLX15-SC and DARZALEX FASPRO® Combined With Lenalidomide and Dexamethasone in Transplant-ineligible Newly Diagnosed Multiple Myeloma Patients
Led by Shanghai Henlius Biotech · Updated on 2026-05-22
258
Participants Needed
81
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetic similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC compared to US-DARZALEX FASPRO® in patients newly diagnosed with multiple myeloma (MM) who are not eligible for transplant. This phase 1 randomized, double-blind study aims to understand how these treatments perform when combined with lenalidomide and dexamethasone (Rd) in this patient group. The study is sponsored by Shanghai Henlius Biotech and focuses on transplant-ineligible MM patients with measurable disease and good performance status. Participants will receive either HLX15-SC or US-DARZALEX FASPRO® via subcutaneous injections at a dose of 1800 mg weekly for the first 8 weeks (Cycles 1-2) and every two weeks during Weeks 9-16 (Cycles 3-4), with each cycle lasting 4 weeks. After completing 4 treatment cycles, based on clinical benefit and participant preference, patients may continue to receive the locally marketed daratumumab subcutaneous formulation combined with Rd for up to 32 weeks or until loss of benefit, death, unacceptable toxicity, withdrawal, or other protocol reasons. Following this period, participants will receive standard care according to local guidelines, which may include daratumumab. Throughout the study, participants will undergo evaluations including pharmacokinetic assessments at 7 days and 16 weeks, safety monitoring through adverse events, vital signs, physical exams, lab tests, and electrocardiograms, as well as immunogenicity and efficacy assessments such as overall response rate and time to response. The total treatment duration is up to 32 weeks, followed by continued standard care. These measures help researchers understand treatment effects, safety, and patient response over time.
CONDITIONS
Brief Title
A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Body mass index between 18.5 and less than 28 kg/m2
- Voluntary participation with signed informed consent
- Documented diagnosis of multiple myeloma with measurable lesions
- Serum albumin 35 g/L or higher
- Newly diagnosed, untreated, and deemed ineligible for high-dose chemotherapy with autologous stem cell transplant
- ECOG performance status of 0 or 1
- Clinical laboratory values meeting specified minimum hemoglobin, neutrophil count, liver function, creatinine clearance, calcium levels, and platelet counts
- Use of contraception consistent with local regulations during and after the study as specified
- Negative pregnancy test for women of childbearing potential at screening
You will not qualify if you...
- Diagnosis of primary amyloidosis, MGUS, smoldering multiple myeloma, Waldenström's disease, or other IgM M-protein conditions without clonal plasma cell infiltration
- Plasma cell leukemia or POEMS syndrome
- Prior or current systemic therapy or stem cell transplant for multiple myeloma, except short corticosteroid use before randomization
- Peripheral neuropathy or neuropathic pain grade 2 or higher
- History of malignancy other than multiple myeloma within 3 years, except certain skin or cervical cancers
- Clinical signs of meningeal involvement of multiple myeloma
- Known chronic obstructive pulmonary disease or recent asthma history
- Known HIV or treponema pallidum antibody positivity
- Active hepatitis B or C infection
- Concurrent medical or psychiatric conditions that interfere with study participation
- Clinically significant cardiac disease or ECG abnormalities
- Known allergies or intolerance to study drugs or components
- History of drug or substance abuse within 1 year
- Pregnancy, breastfeeding, or plans for pregnancy or egg/sperm donation during and after study
- Recent radiation therapy, plasmapheresis, significant blood loss, major surgery, or participation in other clinical trials as specified
- Any condition judged by the investigator to compromise patient safety or study results
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks
Participants receive HLX15-SC or DARZALEX FASPRO® combined with Lenalidomide and Dexamethasone. The study drugs are administered subcutaneously weekly for the first 8 weeks and every two weeks for the next 8 weeks.
Weekly visits for Weeks 1-8 and every two weeks for Weeks 9-16
Trial Site Locations
Total: 81 locations
1
Highlands Oncology Group, PA
Springdale, Arkansas, United States, 72762
Actively Recruiting
2
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256
Actively Recruiting
3
D&H National Research Center
Margate, Florida, United States, 33063
Actively Recruiting
4
Ocala Oncology Center
Ocala, Florida, United States, 34474
Actively Recruiting
5
Florida Clinical Trials Group
Plantation, Florida, United States, 33322
Actively Recruiting
6
Florida Clinical Trials Group
Tamarac, Florida, United States, 33321
Actively Recruiting
7
Pontchartrain Cancer Center
Covington, Louisiana, United States, 70433
Actively Recruiting
8
Oncology Consultants (P1 Trials -Exigent Network)
Houston, Texas, United States, 77030
Actively Recruiting
9
American Oncology Network Vista Oncology Division / Physician partner associate
Olympia, Washington, United States, 98506
Actively Recruiting
10
Perth Blood Institute
Perth, Australia, 6005
Actively Recruiting
11
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233000
Actively Recruiting
12
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230031
Actively Recruiting
13
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230601
Actively Recruiting
14
Beijing Chao-Yang Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100027
Actively Recruiting
15
Peking University First Hospital
Beijing, Beijing Municipality, China, 100035
Actively Recruiting
16
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
17
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
18
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350004
Actively Recruiting
19
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361001
Actively Recruiting
20
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510013
Actively Recruiting
21
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
22
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510220
Actively Recruiting
23
Meizhou People's Hospital
Meizhou, Guangdong, China, 514031
Actively Recruiting
24
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
Actively Recruiting
25
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
26
Liuzhou Worker's Hospital
Liuzhou, Guangxi, China, 545007
Actively Recruiting
27
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530213
Actively Recruiting
28
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
Actively Recruiting
29
Affiliated Hospital of Hebei University
Baoding, Hebei, China, 071030
Actively Recruiting
30
Cangzhou People's Hospital
Cangzhou, Hebei, China, 061000
Actively Recruiting
31
Hebei medical university third hospital
Shijiazhuang, Hebei, China, 050052
Actively Recruiting
32
The Second Hospital of Hebei Medical Universit
Shijiazhuang, Hebei, China, 050071
Actively Recruiting
33
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150069
Actively Recruiting
34
The First Affiliated Hospital of Henan University of Science & Techinology
Luoyang, Henan, China, 471003
Actively Recruiting
35
Xinxiang Central Hospital
Xinxiang, Henan, China, 453000
Actively Recruiting
36
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
37
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
38
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
39
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430014
Actively Recruiting
40
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
41
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430061
Actively Recruiting
42
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
43
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
44
The First Affiliated Hospital Of University South China
Hengyang, Hunan, China, 421001
Actively Recruiting
45
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China, 010030
Actively Recruiting
46
The First Affiliated Hospital of Nanchang University
Nanchang, Jangxi, China, 330008
Actively Recruiting
47
The second affiliated hospital of Nanchang University
Nanchang, Jangxi, China, 330008
Actively Recruiting
48
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
49
Sir Run Run Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 211166
Actively Recruiting
50
Nuclear Industry General Hospital (The Second Affiliated Hospital of Soochow University)
Suzhou, Jiangsu, China, 215004
Actively Recruiting
51
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China, 214000
Actively Recruiting
52
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221006
Actively Recruiting
53
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China, 341000
Actively Recruiting
54
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Actively Recruiting
55
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China, 116001
Actively Recruiting
56
The First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Actively Recruiting
57
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
58
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110041
Actively Recruiting
59
Shandong Provincial Hospital
Jinan, Shandong, China, 250022
Actively Recruiting
60
Jining No.1 People's Hospital
Jining, Shandong, China, 272000
Actively Recruiting
61
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266001
Actively Recruiting
62
Weifang People's Hospital
Weifang, Shandong, China, 261041
Actively Recruiting
63
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
64
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Actively Recruiting
65
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030013
Actively Recruiting
66
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
67
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610073
Actively Recruiting
68
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
69
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China, 300131
Actively Recruiting
70
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300308
Actively Recruiting
71
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
72
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310015
Actively Recruiting
73
Sir Run Run Shaw Hospital Zhejiang University School of Medicine（The Grand Canal Campus）
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
74
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310020
Actively Recruiting
75
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315010
Actively Recruiting
76
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
77
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, Georgia, 0159
Not Yet Recruiting
78
LLC Caucasus Medical Centre
Tbilisi, Georgia, 0160
Not Yet Recruiting
79
Clinical Hospital Centre Zemun
Belgrade, Serbia, 11080
Not Yet Recruiting
80
University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Not Yet Recruiting
81
University Clinical Center Nis
Niš, Serbia, 8000
Not Yet Recruiting
Research Team
Y
Yinping Zhong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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