Two Schemes Response in Multiple Myeloma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorHospital General de Mexico
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Clinical records of patients diagnosed with multiple myeloma treated at Hospital General de México between 2020 and 2023.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Bortezomib
DrugBortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (14,15) (VTD)
Treatment groups
83 Participants
are divided into 2 treatment groupsGroup A: Control Group1 intervention
Group B: Bortezomib Group1 intervention
Trial outcomes
Primary outcomes
1
Favorable Response
Criteria established with the International Multiple Myeloma Working Group
Time frame
Post-induction (6 months)2
Time to next treatment
Need for a secondline treatment after induction
Time frame
Post-induction (2 years)Secondary outcomes
1
Overall survival
Survivorship passing 3000 days
Time frame
3000 daysSponsors and contacts
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Source ClinicalTrials.gov