Response, Acute PhaseNCT06284395
Two Schemes Response in Multiple Myeloma
An observational study of Response, Acute Phase and Survivorship, run by Hospital General de Mexico at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Response, Acute Phase, Survivorship
- What is being tested?
- Bortezomib
- How many people
- 83 participants
- Where
- 1 siteMexico
- Study dates
- 20 Nov 2023to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical records of patients diagnosed with multiple myeloma treated at Hospital General de México between 2020 and 2023.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de Mexico Dr. Eduardo Liceaga
Mexico City, Mexico City, 06720
Christian O Ramos Peñafiel, PhD, 5523351588, leukemiachop33@gmail.com
Adan G Gallardo Rodriguez, +525584005072, nutriologo.agallardo8@gmail.com
About this study
Official title: Bortezomib, Thalidomide, and Dexamethasone Versus Thalidomide and Dexamethasone for Response Rates in Multiple Myeloma Patients: a Retrospective Study
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.
Read the 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.
- Conditions
- Response, Acute Phase, Survivorship
- Being tested
- Bortezomib
- Keywords
- Multiple Myeloma, Bortezomib, Thalidomide, Acute Phase Response, Survival
- Medical subject headings
- Acute-Phase Reaction, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Intervention Group
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Favorable Response
Criteria established with the International Multiple Myeloma Working Group
Measured: Post-induction (6 months)
Time to next treatment
Need for a secondline treatment after induction
Measured: Post-induction (2 years)
Secondary outcomes (1)
Overall survival
Survivorship passing 3000 days
Measured: 3000 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start20 Nov 2023
- Primary completion20 Mar 2024
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Response, Acute PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Christian Omar Ramos-Peñafiel, MD, PhD, Hospital General de Mexico
- Investigators
- Adolfo O Martinez Tovar, PhD, Study director, Hospital General de México Dr. Eduardo Liceaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284395
- Sponsor's protocol ID
- HGM1471-002/24
- Status last verified
- Sep 2024
- First submitted
- 14 Feb 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.
Publications
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.
PubMed 31392724Mersin 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.
PubMed 33947178
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bortezomib, Thalidomide, and Dexamethasone Versus Thalidomide and Dexamethasone for Response Rates in Multiple Myeloma Patients: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06284395
- Acronym / sponsor ID
- HGM1471-002/24
- Conditions
- Response, Acute Phase, Survivorship
- Keywords
- Multiple Myeloma, Bortezomib, Thalidomide, Acute Phase Response, Survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Drug: BortezomibThalidomide 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 | – | Drug: BortezomibBortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (VTD). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical records of patients diagnosed with multiple myeloma treated at Hospital General de México between 2020 and 2023.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BortezomibAlso: Intervention GroupBortezomib 1.3mg/m2 SC on days 1,4, 8,11 to the TD scheme for a total of 6 treatment cycles (14,15) (VTD) | Drug | Bortezomib Group, Control Group |
Primary outcome
Favorable Response
Time frame: Post-induction (6 months)
Criteria established with the International Multiple Myeloma Working Group
Time to next treatment
Time frame: Post-induction (2 years)
Need for a secondline treatment after induction
1 secondary outcome
Overall survival
Time frame: 3000 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Results publication: PubMed 31392724de 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.
- Results publication: PubMed 33947178Mersin 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.
- Individual participant dataSharing planned: No. All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adolfo O Martinez Tovar, PhD study director
Hospital General de México Dr. Eduardo Liceaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Response, Acute Phase and Survivorship, run by Hospital General de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian O Ramos Peñafiel, PhD (+52 55 27892000 ext. 2020, leukemiachop33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Favorable Response (time frame: Post-induction (6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284395, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.