Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Survivorship passing 3000 days | 3000 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Clinical records of patients diagnosed with multiple myeloma treated at Hospital General de México between 2020 and 2023.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian O Ramos Peñafiel, PhD | Contact | +52 55 27892000 | 2020 | leukemiachop33@gmail.com |
| Adán G Gallardo Rodriguez, PhD | Contact | +52 55 27892000 | 2020 | nutriologo.agallardo8@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Adolfo O Martinez Tovar, PhD | Hospital General de México Dr. Eduardo Liceaga | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Mexico Dr. Eduardo Liceaga | Recruiting | Mexico City | Mexico City | 06720 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31392724 | Result | 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. | |
| 33947178 |
Not provided
Not provided
All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000210 | Acute-Phase Reaction |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Result |
| 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. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |