NCT06284395

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

February 14, 2024

Last Update Submit

September 30, 2024

Conditions

Response, Acute PhaseSurvivorship

Keywords

Multiple MyelomaBortezomibThalidomideAcute Phase ResponseSurvival

Outcome Measures

Primary Outcomes (2)

  • Favorable Response

    Criteria established with the International Multiple Myeloma Working Group

    Post-induction (6 months)

  • Time to next treatment

    Need for a secondline treatment after induction

    Post-induction (2 years)

Secondary Outcomes (1)

  • Overall survival

    3000 days

Study Arms (2)

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.

Drug: Bortezomib

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).

Drug: Bortezomib

Interventions

BortezomibDRUG

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)

Also known as: Intervention Group
Bortezomib GroupControl Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical records of patients diagnosed with multiple myeloma treated at Hospital General de México between 2020 and 2023.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de Mexico Dr. Eduardo Liceaga

Mexico City, Mexico City, 06720, Mexico

RECRUITING

Related 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 clinical outcomes in the Latin America Haemato-Oncology (HOLA) Observational Study, 2008-2016. Br J Haematol. 2020 Feb;188(3):383-393. doi: 10.1111/bjh.16124. Epub 2019 Aug 7.

    PMID: 31392724BACKGROUND

  • 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: 10.4274/tjh.galenos.2021.2020.0555. Epub 2021 May 5.

    PMID: 33947178BACKGROUND

MeSH Terms

Conditions

Acute-Phase ReactionMultiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Adolfo O Martinez Tovar, PhD

    Hospital General de México Dr. Eduardo Liceaga

    STUDY DIRECTOR

Central Study Contacts

Christian O Ramos Peñafiel, PhD

CONTACT

+52 55 27892000leukemiachop33@gmail.com

Adán G Gallardo Rodriguez, PhD

CONTACT

+52 55 27892000nutriologo.agallardo8@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 28, 2024

Study Start

November 20, 2023

Primary Completion

March 20, 2024

Study Completion

October 30, 2024

Last Updated

October 2, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.

Locations

ME(1)