Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma

September 27, 2022 updated by: The First Affiliated Hospital of Soochow University

Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma With Renal Dysfunction in Real-World: A Non-interventional Prospective Multicenter Observational Study

This is an observational, multi-center, non-interventional study, which is designed to evaluate the safety and efficacy of daratumumab in Combination with Bortezomib, Thalidomide, and Dexamethasone (D-VTD) Regimens in NDMM patients with renal dysfunction in real-world clinical practice. The data collected in this trial are for subjects with NDMM and renal dysfunction treated with D-VTd regimen and consist of 2 treatment phases, efficacy and safety data from induction phase and consolidation phase.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. newly diagnosed MM;
  2. age over 18 years, male or female;
  3. glomerular filtration rate (eGFR) < 40 mL/min
  4. patients who completed at least one course of treatment were included in the safety observation;
  5. Patients who completed at least 2 courses of treatment were included in the efficacy observation;

Description

Inclusion Criteria:

  1. newly diagnosed multiple myeloma;
  2. age over 18 years, male or female;
  3. glomerular filtration rate (eGFR) < 40 mL/min
  4. Patients must have the ability to understand and voluntarily sign the informed consent form, which must be signed before any trial process;
  5. patients who completed at least one course of treatment were included in the safety observation;
  6. Patients who completed at least 2 courses of treatment were included in the efficacy observation;

Exclusion Criteria:

  1. acute and chronic renal insufficiency not caused by myeloma;
  2. are receiving any other investigational drug or investigational medical device;
  3. Patients with other cancers confirmed before MM diagnosis, except cervical carcinoma in situ or scaly cell carcinoma of the skin and basal cell carcinoma that are considered cured for more than 3 years before enrollment;
  4. patients who do not complete a course of DVTd treatment for any reason, unless permanent discontinuation or death due to the drug;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Very good partial response (VGPR) rate
Time Frame: 28 days after consolidation therapy
28 days after consolidation therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

September 30, 2025

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-VTD-MM07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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