Two Schemes Response in Multiple Myeloma

Recruiting

• Conditions: Response, Acute Phase; Survivorship
• Interventions: Drug: Bortezomib

• Registration Number: NCT06284395
• Lead Sponsor: Hospital General de Mexico

Brief Summary

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.

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 Timeline

• Study Start: 2023-11-20
• Study First Submitted: 2024-02-14
• Study First Submitted QC: 2024-02-26
• Study First Posted: 2024-02-28
• Primary Completion: 2024-03-20
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival	3000 days	Survivorship passing 3000 days

Trial Locations

Locations (1)

Hospital General de Mexico Dr. Eduardo Liceaga; 🇲🇽 Mexico City, Cdmx, Mexico