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Two Schemes Response in Multiple Myeloma

H

Hospital General de Mexico

Status

Enrolling

Conditions

Response, Acute Phase
Survivorship

Treatments

Drug: Bortezomib

Study type

Observational

Funder types

Other

Identifiers

NCT06284395
HGM1471-002/24

Details and patient eligibility

About

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.

Full 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.

Enrollment

83 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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 design

83 participants in 2 patient groups

Control Group
Description:
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.
Treatment:
Drug: Bortezomib
Bortezomib Group
Description:
Bortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (VTD).
Treatment:
Drug: Bortezomib

Trial contacts and locations

1

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Central trial contact

Christian O Ramos Peñafiel, PhD; Adán G Gallardo Rodriguez, PhD

Data sourced from clinicaltrials.gov

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