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

This study is ongoing, but not recruiting participants.
Mundipharma Pharmaceuticals B.V.
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
PETHEMA Foundation Identifier:
First received: June 15, 2011
Last updated: April 8, 2015
Last verified: April 2015

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.

Condition Intervention Phase
Multiple Myeloma
Drug: Bendamustine
Drug: Velcade
Drug: Prednisone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by PETHEMA Foundation:

Primary Outcome Measures:
  • Efficacy in terms of response rate and complete response rate (CR and near CR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety in terms of toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Time to progresion [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Progresion free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Global survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Detailed Description:

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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • Patient with peripheral neuropathy grade ³ 2 within 14 days prior to its inclusion in the trial
  • 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 who has had a myocardial infarction within 6 months prior to inclusion in the clinical trial or has a functional class III or IV according to the New York Heart Association (NYHA) heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias or acute ischemia detected electrocardiographically or conduction system disorders.
  • Patient who has received any investigational agent within 30 days prior their inclusion or is currently in another clinical trial or receiving any investigational agent
  • Patient undergoing major surgery within 30 days before inclusion in the study
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01376401

Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clínic
Barcelona, Spain
Institut català d'Oncología
Barcelona, Spain
MD Anderson Internacional
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital General Morales Messeguer
Murcia, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Universitario Virgen del Rocío
Sevilla, Spain
Hospital Universitario La Fe
Valencia, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain
Sponsors and Collaborators
PETHEMA Foundation
Mundipharma Pharmaceuticals B.V.
Janssen-Cilag Ltd.
  More Information

Additional Information:
CRO  This link exits the site

No publications provided by PETHEMA Foundation

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: PETHEMA Foundation Identifier: NCT01376401     History of Changes
Other Study ID Numbers: BenVelPres
Study First Received: June 15, 2011
Last Updated: April 8, 2015
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Vascular Diseases
Alkylating Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 24, 2015