A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants with Smoldering Multiple Myeloma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

- diagnosis of smoldering multiple myeloma (SMM) for less than 5 years
- have a confirmed diagnosis of intermediate or high-risk SMM, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion Criteria

- Active multiple myeloma, requiring treatment as defined by the study protocol
- Primary systemic AL (immunoglobulin light chain) amyloidosis
- Prior or concurrent exposure to any of the following: approved or investigational treatments for SMM or/and multiple myeloma, daratumumab or other anti CD-38 therapies, treatment with bone-protecting agents (eg, bisphosphonates, denosumab) or corticosteroids with a dose not exceeding 10 mg prednisone per day or equivalent are only allowed if given in a stable dose and for a nonmalignant condition, or received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1
- history of malignancy (other than SMM) within 3 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
- known chronic obstructive pulmonary disease (COPD) OR moderate or severe persistent asthma within the past 2 years
- any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To evaluate if daratumumab can effectively decrease M protein in subjects with intermediate or high-risk SMM as assessed by CR rate<br>- To determine if daratumumab reduces the progression/death rate in subjects with intermediate or high-risk SMM;Secondary Objective: - To evaluate preliminary efficacy, including Overall Response Rate (ORR) and progressionfree survival (PFS)<br>- To evaluate the minimal residual disease (MRD) negative rate<br>- To evaluate the pharmacokinetics and immunogenicity of daratumumab<br>- To assess the safety profile of daratumumab given in 3 different dosing schedules<br>- To determine if daratumumab has an effect on QT interval;Primary end point(s): 1. The percentage of participants who achieve a complete response (CR)<br>2. The percentage of participants that have an event (disease progression or death) per patient-year;Timepoint(s) of evaluation of this end point: Up to approximately 24 months for point 1.<br>Up to approximately 30 months for point 2.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. The percentage of participants who are minimal residual disease (MRD) negative.<br>2. Time to next treatment (TNT).<br>3. The percentage of participants who achieve a Complete Response (CR) or a Partial Response (PR)<br>4. The median time of progression free survival (PFS)<br>5. The percentage of participants with symptomatic multiple myeloma<br>6. Response to first subsequent multiple myeloma treatment<br>7. Overall survival rate;Timepoint(s) of evaluation of this end point: Up to 5.5 years

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