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Trial Title:
Real-World Use of Selinexor, Daratumumab and Dexamethasone in Chinese Patients With Multiple Myeloma at First Relapse
NCT ID:
NCT05559788
Condition:
Multiple Myeloma at First Relapse
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Recurrence
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Study pop:
Participants with MM who who are first relapsed and will start treatment with selinexor,
daratumumab and dexamethasone in a real-world clinical practice setting will be bserved
prospectively.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 20, 2022
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Fu chengcheng PhD
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05559788
