Bendamustine, Bortezomib (Velcade ®) and Prednisone (BVP) in Patients Newly Diagnosed Multiple Myeloma

NCT01376401 | Completed Phase 2 DMC

• 1 other identifier: BenVelPres
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Efficacy in terms of response rate and complete response rate (CR and near CR)

  1 year

Secondary Outcomes (4)

• Safety in terms of toxicity

  1 year

• Time to progresion

  3 years

• Progresion free survival

  2 years

• Global survival

  3 years

Interventions

Bendamustine DRUG

Velcade DRUG

Prednisone DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age greater than or equal to 18 at the time of signing Informed consent
• Patient who has voluntarily signed informed consent before conduct of the trial any evidence that is not part of care normal patients, with the knowledge of the patient that can leave the trial at any time he want
• Patient able, in the opinion of the physician to comply with the visitation schedule and other requirements of the protocol
• Patient newly diagnosed symptomatic multiple myeloma based on standard criteria and has not received any previous treatment of chemotherapy for MM.
• Patients with newly diagnosed multiple myeloma, secretory, or oligosecretor or not secretor if it has soft tissue plasmacytomas.
• Patients with non-secretory MM oligosecretor or without white tissue plasmacytomas be excluded to keep a group of patients with characteristics similar to the previous study with which we compare the results.
• Patients with measurable disease, defined by the following 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)
• ECOG PS ≤ 2
• Expectations of life than 3 months.
• The patient has the following laboratory values within 28 days before the baseline visit:
• 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

You may not qualify if:

• Patient has previously received treatment for multiple myeloma with Pulse steroids except for some emergency that requires it before start of induction therapy, administration of bisphosphonates or radiation therapy, or analgesic due to the presence of plasmacytomas, which require it for some urgency.
• Patients with non-measurable disease.
• Patients with hypersensitivity to bortezomib, boric acid, or bendamustine mannitol
• Patient to be known carrier of the virus HIV (human immunodeficiency) surface antigen of hepatitis B virus or who has active infection virus hepatitis C.
• Patient pregnant or breastfeeding
• Patients with acute diffuse infiltrative pulmonary disease and / or disease pericardium
• History of other malignancies after different myeloma (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) to unless the patient is free of the disease beyond 5 years
• Hypertension arterial or poorly controlled diabetes mellitus or any other disease severe organ involving an unreasonable risk to the patient
• Any psychiatric disorder that interferes with comprehension of consent informed or prevent the normal discharge that requires participation in this trial
• Patients with major psychiatric history.

Sponsors & Collaborators

• PETHEMA Foundation: lead
• Mundipharma Pharmaceuticals B.V.: collaborator
• Janssen-Cilag Ltd.: collaborator

Study Sites (14)

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Location

Hospital Clínic

Barcelona, Spain

Location

Institut català d'Oncología

Barcelona, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario de la Princesa

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

MD Anderson Internacional

Madrid, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Location

Hospital General Morales Messeguer

Murcia, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain

Location

Related Publications (1)

• 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.

  PMID: 25911554 DERIVED

Related Links

• Spanish Association of Hematology

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bendamustine Hydrochloride; Bortezomib; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 20, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

ES (14)