Two Schemes Response in Multiple Myeloma

September 30, 2024 updated by: Christian Omar Ramos-Peñafiel, MD, PhD, Hospital General de Mexico

Bortezomib, Thalidomide, and Dexamethasone Versus Thalidomide and Dexamethasone for Response Rates in Multiple Myeloma Patients: a Retrospective Study

Retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The most current treatment of multiple myeloma is based on a combination of drugs, including immunomodulators, proteasome inhibitors, etc. The VTD (bortezomib, thalidomide, and dexamethasone) and TD (thalidomide and dexamethasone) regimens are commonly used as a first-line treatment due to limited resources. The study aimed to compare the proportion of favorable responses, survival, and time to the next treatment between two different treatment approaches. The investigators designed a retrospective study based on medical records of patients with multiple myeloma, eligible for stem cell transplantation, who received, first-line, the VTD or TD combination.

Study Type

Observational

Enrollment (Estimated)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Cdmx
      • Mexico City, Cdmx, Mexico, 06720
        • Recruiting
        • Hospital General de México Dr. Eduardo Liceaga
        • Contact:
        • Contact:
        • Contact:
          • Juan M Cano Calderón, MD
        • Contact:
          • Juan F Zazueta Pozos, MD
        • Contact:
          • Adán G Gallardo Rodriguez, PhD
        • Contact:
          • Carlos Martínez Murillo, PhD
        • Contact:
          • Irma Olarte Carrillo, PhD
        • Contact:
          • Adolfo Martínez Tovar, PhD
        • Contact:
          • Christian O Ramos Peñafiel, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Clinical records of patients diagnosed with multiple myeloma treated at Hospital General de México between 2020 and 2023.

Description

Inclusion Criteria:

  • clinical records of patients who were considered eligible for transplant due to their functional status and who were given some treatment strategy comprising a combination of drugs.

Exclusion Criteria:

  • Incomplete clinical records
  • Clinical records of patients who abandoned treatment or could not continue with the treatment due to economic or distance issues
  • Clinical records of patients who presented severe sepsis before the beginning of either treatment

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Thalidomide 100mg-200mg PO daily alone or in combination with dexamethasone 40mg PO every 24 hours on days 1-4, 8-11 of each cycle.
Drug: Bortezomib
Bortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (14,15) (VTD)
Other Names:
  • Intervention Group
Bortezomib Group
Bortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (VTD).
Drug: Bortezomib
Bortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (14,15) (VTD)
Other Names:
  • Intervention Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Favorable Response
Time Frame: Post-induction (6 months)
Criteria established with the International Multiple Myeloma Working Group
Post-induction (6 months)
Time to next treatment
Time Frame: Post-induction (2 years)
Need for a secondline treatment after induction
Post-induction (2 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3000 days
Survivorship passing 3000 days
3000 days

Collaborators and Investigators

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

Sponsor

Hospital General de Mexico

Investigators

  • Study Director: Adolfo O Martinez Tovar, PhD, Hospital General de México Dr. Eduardo Liceaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 20, 2023

Primary Completion (Actual)

March 20, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HGM1471-002/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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