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

NCT05559788 | Unknown

• 1 other identifier: SDd-MM06
• Study Type: observational
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Myeloma at First Relapse

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  ORR is defined as the percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) based on the review of the myeloma response data assessed by International Myeloma Working Group (IMWG) criteria.

  28 days after the last therapy

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
• Subjects must have previously received 1 anti-myeloma regimens. Subjects must have documented disease progression
• Age ≥18 years;
• Life expectancy \> 6 months;
• patients should provide available clinical case files and/or detailed records of medical history, diagnosis and treatment information, and cooperate with clinical management;
• 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.

You may not qualify if:

• Patients who are contraindicated as per product label of XDd;
• Known positive for HIV or active hepatitis B or C or other infectious diseases;
• Pregnancy or lactation;
• 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);
• 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;
• Patients who are unsuitable for this study judged by clinicians.

Sponsors & Collaborators

• Fu chengcheng PhD: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: September 29, 2022
• Study Start: September 20, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: September 29, 2022

Record last verified: 2022-09