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NCT Number: NCT06284395

Two Schemes Response in Multiple Myeloma

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.

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Key information

Conditions

Response, Acute Phase Acute-Phase Reaction Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Inflammation Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Survivorship Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General de Mexico Dr. Eduardo Liceaga

Mexico City, 06720, Mexico

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bortezomib

Drug

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

Primary outcomes

  1. Favorable Response

    Time frame: Post-induction (6 months)

    Criteria established with the International Multiple Myeloma Working Group

  2. Time to next treatment

    Time frame: Post-induction (2 years)

    Need for a secondline treatment after induction

Secondary outcomes

  1. Overall survival

    Time frame: 3000 days

    Survivorship passing 3000 days

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hospital General de Mexico

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 28, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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