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Compares treatment options for Multiple Myeloma (MM)
Official 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
ClinicalTrials.gov ID: NCT07477587
What this study is testing
What is HLX15-SC-Rd?
HLX15-SC-Rd is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for multiple myeloma (mm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
- people 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...
- Serum albumin ≥ 35 g/L.
You likely can't join if
- Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM)...
- 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 ≥...
- 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...
- Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for...
- Patient has a history of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell...
- Patient has clinical signs of meningeal involvement of MM.
See the full eligibility criteria
Who can join
- 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.
- people 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 \ 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 × 109/L for all other patients (transfusion within 3 days prior to randomization to achieve the minimum platelet count is not permitted).
- Contraceptive criteria: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Female patients: a female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP: must...
- Male patients: male patients are eligible to participate if they agree to the following during the intervention period and for at least 140 days following the last dose of study products: Be abstinent from heterosexual...
- A WOCBP must have a negative serum pregnancy test at screening within 72 h prior to randomization. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease...
What rules you out
- 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...
- 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...
- 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...
- 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 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...
- 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...
- 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...
- Cardiac arrhythmia (NCI-CTCAE Version 6 Grade ≥ 2) or clinically significant ECG abnormalities.
- Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) (See Appendix 6) \> 470 ms.
- Patient has known allergies, hypersensitivity, or intolerance to lenalidomide, corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products.
- Patient has history of drug abuse or substance abuse one year prior to randomization. Patient is known or suspected of not being able to comply with the study protocol (e.g., because of alcoholism, drug dependency, or...
- Patient is a woman who is pregnant, or breast-feeding, or planning to become pregnant or donate eggs (ova, oocytes) while enrolled in this study or within 140 days after the last dose of study products. Or patient is a...
- Patient had radiation therapy within 14 days of randomization.
- Patient had plasmapheresis within 28 days of randomization.
- Patient had a history of blood donation or total blood loss of 200 mL or more within 3 months before randomization.
- Patient had major surgery within 28 days before randomization or has not fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 28 days after...
- Patient in clinical trials of any other drug or device within 3 months (or 5 half-lives of the corresponding investigational product if the half-life of the drug is long [5 half-lives \> 3 months]) before randomization.
- Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the...
The study team makes the final eligibility decision.
Where it's taking place
- Springdale, Arkansas, United States
- Jacksonville, Florida, United States
- Margate, Florida, United States
- Ocala, Florida, United States
- Plantation, Florida, United States
- Tamarac, Florida, United States
- Covington, Louisiana, United States
- Houston, Texas, United States
- Olympia, Washington, United States
- Perth, Australia
- Bengbu, Anhui, China
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Guangzhou, Guangdong, China
- Meizhou, Guangdong, China
- Shenzhen, Guangdong, China
- Liuzhou, Guangxi, China
+ 37 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Springdale, Arkansas, United States; Jacksonville, Florida, United States; Margate, Florida, United States; Ocala, Florida, United States; Plantation, Florida, United States; Tamarac, Florida, United States and 51 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.