Real-World Use of Selinexor, Daratumumab and Dexamethasone in Chinese Patients With Multiple Myeloma at First Relapse

Study Purpose

This is a single-arm, prospective, non-interventional, real-world study to observe and evaluate the efficacy and safety of selinexor in combination with daratumumab and dexamethasone in patients with multiple myeloma at first relapse.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma. 2. Subjects must have previously received 1 anti-myeloma regimens. Subjects must have documented disease progression. 3. Age ≥18 years; 4. Life expectancy > 6 months; 5. patients should provide available clinical case files and/or detailed records of medical history, diagnosis and treatment information, and cooperate with clinical management; 6. Fertile women and men whose partner is of childbearing potential or pregnant should agree to practice complete abstinence or to use a condom during therapy and dose interruptions and for 90 days after the last treatment.

Exclusion Criteria:

1. Patients who are contraindicated as per product label of XDd; 2. Known positive for HIV or active hepatitis B or C or other infectious diseases; 3. Pregnancy or lactation; 4. Patients with a history of malignant tumor that may affect the implementation or results analysis of this study (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, intramucosal carcinoma of the gastrointestinal tract in situ, and localized prostate cancer); 5. Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results; 6. Patients who are unsuitable for this study judged by clinicians.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05559788
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Fu chengcheng PhD
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma at First Relapse

Additional Details

This is a non-interventional, prospective, observational post-marketing surveillance study of selinexor, daratumumab and dexamethasone in participants with multiple myeloma (MM). The study will assess the safety and effectiveness of selinexor in combination with daratumumab and dexamethasone (XDd) for first relapse MM patients under real-world conditions. The study will enroll approximately 34 participants. The data will be prospectively collected, at our center from medical files and recorded into electronic case report forms (e-CRFs). The overall duration of the study will be approximately 3 years. Data will be collected over and up to a 12 months-surveillance period (per participant) once enrolled.

Arms & Interventions

Arms

: Participants With Multiple Myeloma

Participants with MM who are first relapsed and will start treatment with selinexor, daratumumab and dexamethasone in a real-world clinical practice setting will be observed prospectively for approximately up to 1 year.

Interventions

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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