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
A Randomized, Double-blind, Parallel-controlled Phase I Study to Compare the Pharmacokinetic 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
1 other identifier
interventional
258
5 countries
81
Brief Summary
The purpose of this study is to compare the pharmacokinetic (PK) similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC versus US-DARZALEX FASPRO® following single and multiple subcutaneous (SC) injections in newly diagnosed MM patients ineligible for transplant. Participants who meet all inclusion criteria and none of the exclusion criteria will receive either the HLX15-SC-Rd regimen or the D-Rd regimen for 4 cycles (one cycle = 4 weeks). After 4 cycles of treatment, based on clinical benefit and participant preference, participants may continue to receive the locally marketed daratumumab subcutaneous formulation (Dara-SC) in combination with Rd according to clinical practice, up to 32 weeks or until loss of clinical benefit, death, unacceptable toxicity, withdrawal of informed consent, or any other protocol-specified reason, whichever occurs first. After 32 weeks of dosing, participants will continue to receive appropriate standard of care according to local guidelines (including marketed Dara-SC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2026
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2026
CompletedFirst Posted
Study publicly available on registry
March 17, 2026
CompletedStudy Start
First participant enrolled
May 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 22, 2028
May 22, 2026
May 1, 2026
12 months
February 27, 2026
May 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
pharmacokinetic (PK) similarity
Area under the serum concentration-time curve from time 0 to day 7 (AUC0-7d) after the 1st dose.
7 days
pharmacokinetic (PK) similarity
The maximum (peak) serum drug concentration (Cmax) after the 1st dose.
7 days
pharmacokinetic (PK) similarity
Area under the serum concentration-time curve within a dosing interval at steady-state (AUCss) after the 12th dose
16 weeks
pharmacokinetic (PK) similarity
The maximum (peak) serum drug concentration at steady-state (Cmax,ss) after the 12th dose
16 weeks
Secondary Outcomes (18)
PK characteristics
16 weeks
PK characteristics
16 weeks
Safety: Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
16 weeks
Safety: Vital Signs
16 weeks
Safety: Vital Signs
16 weeks
- +13 more secondary outcomes
Study Arms (2)
HLX15-SC-Rd
EXPERIMENTALHLX15-SC-Rd
US-DARZALEX FASPRO®-Rd
ACTIVE COMPARATORUS-DARZALEX FASPRO®-Rd
Interventions
Subjects will receive 1800 mg HLX15-SC via SC administration for up to 16 weeks: weekly during Week 1-8 (Cycle 1-2; 1 cycle = 4 weeks) and every two weeks during Week 9-16 (Cycle 3-4).
Subjects will receive 1800 mg US-DARZALEX FASPRO® via SC administration for up to 16 weeks: weekly during Week 1-8 (Cycle 1-2; 1 cycle = 4 weeks) and every two weeks during Week 9-16 (Cycle 3-4).
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years at the time of signing the informed consent form (ICF).
- Body mass index (BMI): 18.5 kg/m2 ≤ BMI \< 28 kg/m2.
- Subjects must participate voluntarily, understand the study, and sign the ICF.
- Patients must have a documented diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) criteria, with measurable lesion .
- Serum albumin ≥ 35 g/L.
- Newly diagnosed, untreated, and considered ineligible for high-dose chemotherapy with autologous stem cell transplantation (ASCT) by the investigator.
- The patient's ECOG performance status must be 0 or 1 .
- Patient must have clinical laboratory values meeting the following criteria during the screening period:
- Hemoglobin ≥ 7.5 g/dL (≥ 5 mmol/L; red blood cell \[RBC\] transfusion or use of recombinant human erythropoietin at least 1 week prior to randomization is allowed).
- Absolute neutrophil count (ANC) ≥ 1.0 × 109/L (use of granulocyte-colony stimulating factor \[G-CSF\] is allowed).
- Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).
- Without the following evidence of impaired liver function, including mild impairment (total bilirubin ≤ ULN and AST \> ULN or ULN \< total bilirubin ≤ 1.5 x ULN), moderate impairment (1.5 x ULN \< total bilirubin ≤ 3 x ULN), and severe impairment (total bilirubin \> 3 x ULN).
- Measured creatinine clearance ≥ 40 mL/min .
- Corrected serum calcium \< 14 mg/dL (\< 3.5 mmol/L); or free ionized calcium \< 6.5 mg/dL (\< 1.6 mmol/L) .
- Platelet count ≥ 70 × 109/L for patients with plasma cells \< 50% of bone marrow nucleated cells; platelet count \> 50 × 109/L for all other patients (transfusion within 3 days prior to randomization to achieve the minimum platelet count is not permitted).
- +8 more criteria
You may not qualify if:
- Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
- Patient has plasma cell leukemia (according to IMWG criterion: ≥ 5% of plasma cells in the peripheral blood and/or an absolute plasma cell count of ≥ 2 x 109/L) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
- Patient has prior or current systemic therapy or ASCT for MM, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before randomization.
- Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.
- Patient has a history of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence within 3 years).
- Patient has clinical signs of meningeal involvement of MM.
- Patient has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second \[FEV1\] \< 50% of predicted normal), persistent asthma, or a history of asthma within the last 2 years. Patient with known or suspected COPD or asthma must have a FEV1 test during screening.
- Patient is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have treponema pallidum antibodies (Anti-TP).
- Patient is known to have active hepatitis B or C.
- Patient is seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Patients with resolved infection (that is, patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[Anti-HBc\] and/or antibodies to hepatitis B surface antigen \[Anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded.
- EXCEPTION: Patients with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
- Patient is seropositive for hepatitis C must be screened using PCR measurement of hepatitis C virus (HCV) ribonucleic acid (RNA) levels. Those who are PCR positive will be excluded.
- Patient has any concurrent medical or psychiatric condition or disease (e.g., active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.
- Patient has clinically significant cardiac disease, including:
- Myocardial infarction within 1 year before randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association \[NYHA\] Class III-IV ).
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (81)
Highlands Oncology Group, PA
Springdale, Arkansas, 72762, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
D&H National Research Center
Margate, Florida, 33063, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Florida Clinical Trials Group
Plantation, Florida, 33322, United States
Florida Clinical Trials Group
Tamarac, Florida, 33321, United States
Pontchartrain Cancer Center
Covington, Louisiana, 70433, United States
Oncology Consultants (P1 Trials -Exigent Network)
Houston, Texas, 77030, United States
American Oncology Network Vista Oncology Division / Physician partner associate
Olympia, Washington, 98506, United States
Perth Blood Institute
Perth, 6005, Australia
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230031, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601, China
Beijing Chao-Yang Hospital Capital Medical University
Beijing, Beijing Municipality, 100027, China
Peking University First Hospital
Beijing, Beijing Municipality, 100035, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361001, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510013, China
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510220, China
Meizhou People's Hospital
Meizhou, Guangdong, 514031, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Liuzhou Worker's Hospital
Liuzhou, Guangxi, 545007, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530213, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 071030, China
Cangzhou People's Hospital
Cangzhou, Hebei, 061000, China
Hebei medical university third hospital
Shijiazhuang, Hebei, 050052, China
The Second Hospital of Hebei Medical Universit
Shijiazhuang, Hebei, 050071, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150069, China
The First Affiliated Hospital of Henan University of Science & Techinology
Luoyang, Henan, 471003, China
Xinxiang Central Hospital
Xinxiang, Henan, 453000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430014, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430061, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The First Affiliated Hospital Of University South China
Hengyang, Hunan, 421001, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010030, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jangxi, 330008, China
The second affiliated hospital of Nanchang University
Nanchang, Jangxi, 330008, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Sir Run Run Hospital of Nanjing Medical University
Nanjing, Jiangsu, 211166, China
Nuclear Industry General Hospital (The Second Affiliated Hospital of Soochow University)
Suzhou, Jiangsu, 215004, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214000, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110041, China
Shandong Provincial Hospital
Jinan, Shandong, 250022, China
Jining No.1 People's Hospital
Jining, Shandong, 272000, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266001, China
Weifang People's Hospital
Weifang, Shandong, 261041, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030013, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610073, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300131, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310015, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine（The Grand Canal Campus）
Hangzhou, Zhejiang, 310016, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310020, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, 0159, Georgia
LLC Caucasus Medical Centre
Tbilisi, 0160, Georgia
Clinical Hospital Centre Zemun
Belgrade, 11080, Serbia
University Clinical Center Kragujevac
Kragujevac, 34000, Serbia
University Clinical Center Nis
Niš, 8000, Serbia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2026
First Posted
March 17, 2026
Study Start
May 27, 2026
Primary Completion (Estimated)
May 25, 2027
Study Completion (Estimated)
February 22, 2028
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share