Two Schemes Response in Multiple Myeloma

Survivorship Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284395
• Other study ID #: HGM1471-002/24
• Status: Recruiting
• Start date: November 20, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: February 2024
• Source: Hospital General de Mexico
• Contact: Christian O Ramos Peñafiel, PhD
• Phone: +52 55 27892000
• Email: leukemiachop33[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 83
• Est. completion date: March 30, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-Phase Reaction
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Response, Acute Phase
• Survivorship

Intervention

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)

Locations

Country	Name	City	State
Mexico	Hospital General de Mexico Dr. Eduardo Liceaga	Mexico City	Cdmx

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

de Moraes Hungria VT, Martinez-Banos DM, Penafiel CR, Miguel CE, Vela-Ojeda J, Remaggi G, Duarte FB, Cao C, Cugliari MS, Santos T, Machnicki G, Fernandez M, Grings M, Ammann EM, Lin JH, Chen YW, Wong YN, Barreyro P. Multiple myeloma treatment patterns and — View Citation

Mersin S, Geduk A, Mehtap O, Tarkun P, Unal S, Polat MG, Aygun K, Yenihayat EM, Albayrak H, Hacihanifioglu A. Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. Turk J Haematol. 2021 Aug 25;38(3):211-217. doi: 10.427 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Favorable Response	Criteria established with the International Multiple Myeloma Working Group	Post-induction (6 months)
Primary	Time to next treatment	Need for a secondline treatment after induction	Post-induction (2 years)
Secondary	Overall survival	Survivorship passing 3000 days	3000 days