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Not yet recruitingNCT05559788Updated Sep 29, 2022

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

An observational study in Multiple Myeloma at First Relapse, sponsored by Fu chengcheng PhD. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-29.

Sponsored by Fu chengcheng PhD · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
34
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Myeloma at First Relapse
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 34 is below the median of 140 across 468 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

This is the only study on the registry with Fu chengcheng PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
34 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: 28 days after the last therapy

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05559788
Lead sponsor
Fu chengcheng PhD
Responsible party
Fu chengcheng PhD (Principal Investigator, The First Affiliated Hospital of Soochow University) — Sponsor-investigator
First posted
Sep 29, 2022
Start date
Sep 20, 2022 (estimated)
Primary completion
Jun 1, 2024 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Sep 29, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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