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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by PETHEMA Foundation
Sponsor:
Collaborators:
Mundipharma Pharmaceuticals B.V.
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
PETHEMA Foundation
ClinicalTrials.gov Identifier:
NCT01376401
First received: June 15, 2011
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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 2014
Estimated 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01376401

Locations
Spain
Hospital Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain
Contact: Albert Oriol, Dr       aoriol@iconcologia.net   
Hospital Clínic Recruiting
Barcelona, Spain
Contact: Joan Bladé, Dr       jblade@clinic.ub.es   
Institut català d'Oncología Recruiting
Barcelona, Spain
Contact: Josep Sarra, Dr    34 933 357 011      
Hospital Universitario de la Princesa Recruiting
Madrid, Spain
Contact: Adrián Alegre, Dr       adrian.alegre@telefonica.net   
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain
Contact: Anabelle Chinea, Dr    34 91 336 80 00      
MD Anderson Internacional Recruiting
Madrid, Spain
Contact: Rebeca Iglesias, Dr    34 902 051 058      
Hospital Clínico San Carlos Recruiting
Madrid, Spain
Contact: Rafael Martínez, Dr    34 913 303 000      
Hospital 12 de Octubre Recruiting
Madrid, Spain
Contact: Juan José Lahuerta, Dr       jjlahuerta@telefonica.net   
Hospital General Morales Messeguer Recruiting
Murcia, Spain
Contact: Felipe de Arriba, Dr    34 968 36 09 00      
Hospital Universitario Virgen de la Victoria Recruiting
Málaga, Spain
Contact: Gemma Ramírez, Dr    34 951 03 20 00      
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain
Contact: Consuelo Rayón, Dr       consolacion.rayon@sespa.princast.es   
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain
Contact: Jesús Martín, Dr    34 955 012 000      
Hospital Universitario La Fe Recruiting
Valencia, Spain
Contact: Javier de la Rubia, Dr       delarubia_jav@gva.es   
Hospital Clinico Universitario Lozano Blesa Recruiting
Zaragoza, Spain
Contact: Luis Palomera, Dr    34 976 556 400      
Sponsors and Collaborators
PETHEMA Foundation
Mundipharma Pharmaceuticals B.V.
Janssen-Cilag Ltd.
  More Information

Additional Information:
CRO  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT01376401     History of Changes
Other Study ID Numbers: BenVelPres
Study First Received: June 15, 2011
Last Updated: November 19, 2013
Health Authority: Spain: Ministry of Health

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

ClinicalTrials.gov processed this record on October 16, 2014