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| Name | Class |
|---|---|
| Mundipharma Pharmaceuticals B.V. | INDUSTRY |
| Janssen-Cilag Ltd. | INDUSTRY |
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This protocol corresponds to an open-label national phase II, multicenter, to assess efficacy (in terms of response rate and CR) and toxicity of bendamustine, bortezomib and prednisone (BVP) in 60 patients newly diagnosed MM. Patients in the absence of disease progression or unacceptable toxicity receive up to 9 cycles of BVP. The patients eligible for autologous transplant receive four cycles of BVP, hematopoietic stem cell collection and administration of two cycles BVP over followed by autologous transplant.
In addition to the overall response rates, will also be analyzed time to progression (TTP), progression-free survival (PFS) and overall survival.
Finally, the results will be compared with BVP with those obtained in 120 patients included in our protocol VMP GEM10MAS65.
Patients will be evaluated at scheduled visits up to 3 periods of study:
pretreatment, treatment and monitoring.
Patients included in the study will receive a 6 week cycle consisting of Bendamustine administered IV at doses of 90 mg/m2 on days 1 and 4 of the first cycle and days 1 and 8 in subsequent cycles in combination with Bortezomib as a bolus dose of 1.3 mg/m2 on days 1, 4, 8, 11, 22, 25, 29 and 32, and oral prednisone at doses of 60 mg/m2, during the first four days of each cycle.
Then, patients will receive eight additional cycles of 5-week . The same pattern consisting of bendamustine and prednisone but bortezomib is administered as an intravenous bolus dose of 1.3 mg/m2 on days 1, 8, 15 and 22.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bendamustine | Drug | |||
| Velcade | Drug | |||
| Prednisone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy in terms of response rate and complete response rate (CR and near CR) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety in terms of toxicity | 1 year | |
| Time to progresion | 3 years | |
| Progresion free survival |
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Inclusion Criteria:
For MM secreting measurable disease is defined as any value quantifiable serum monoclonal protein (≥ 1g/dl) and where applicable, a light chain excretion in urine ≥ 200 mg/24 hours. For Multiple Myeloma oligosecretor or secreting measurable disease defined by the presence of soft tissue plasmacytomas (not bone) determined by clinical examination or radiographic methods (eg MRI, CT-Scan)
Platelet count ≥ 100 x 109 / L, hemoglobin ≥ 8.0g/dL and absolute neutrophil count (ANC) ≥ 1.5 x 109 / L; allowed counts under if they are clearly due to a bone marrow infiltration by MM.
Corrected serum calcium <14mg/dL. Aspartate transaminase (AST) ≤ 2.5 x upper limit of normal(LSN) Alanine aminotransferase (ALT) ≤ 2.5 x ULN Total bilirubin within normal limits Serum creatinine <2 mg / dL
- Patients of childbearing potential must use effective contraception during duration of the study and up to 6 months after completion of treatment
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | Spain | |||
| Hospital Clínic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25911554 | Derived | Mateos MV, Oriol A, Rosinol L, de Arriba F, Puig N, Martin J, Martinez-Lopez J, Echeveste MA, Sarra J, Ocio E, Ramirez G, Martinez R, Palomera L, Payer A, Iglesias R, de la Rubia J, Alegre A, Chinea AI, Blade J, Lahuerta JJ, San Miguel JF. Bendamustine, bortezomib and prednisone for the treatment of patients with newly diagnosed multiple myeloma: results of a prospective phase 2 Spanish/PETHEMA trial. Haematologica. 2015 Aug;100(8):1096-102. doi: 10.3324/haematol.2015.124818. Epub 2015 Apr 24. |
| Label | URL |
|---|---|
| Spanish Association of Hematology | View source |
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| 2 years |
| Global survival | 3 years |
| Barcelona |
| Spain |
| Institut català d'Oncología | Barcelona | Spain |
| Hospital 12 de Octubre | Madrid | Spain |
| Hospital Clínico San Carlos | Madrid | Spain |
| Hospital Universitario de la Princesa | Madrid | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Spain |
| MD Anderson Internacional | Madrid | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Spain |
| Hospital General Morales Messeguer | Murcia | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Spain |
| Hospital Universitario La Fe | Valencia | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | Spain |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| 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 |
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| ID | Term |
|---|---|
| D000069461 | Bendamustine Hydrochloride |
| D000069286 | Bortezomib |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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