Two Schemes Response in Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06284395
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospital General de Mexico
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Adolfo O Martinez Tovar, PhD
Principal Investigator Affiliation Hospital General de México Dr. Eduardo Liceaga
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Mexico
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Response, Acute Phase, Survivorship
Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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).

Interventions

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Mexico City, Cdmx, Mexico

Status

Recruiting

Address

Hospital General de Mexico Dr. Eduardo Liceaga

Mexico City, Cdmx, 06720

Site Contact

Christian O Ramos Peñafiel, PhD

leukemiachop33@gmail.com

5523351588