Velcade-Melphalan-Prednisone in Older Untreated Multiple Myeloma Patients.

January 8, 2011 updated by: PETHEMA Foundation

A National, Multi-Center, Open-Label Study of Velcade in Combination With Melphalan and Prednisone (V-MP) in Older Untreated Multiple Myeloma Patients.

This protocol is planned as a multicentric, national, open-label trial designed to evaluate, first, optimal dose of Velcade® (Bortezomib) in combination with melphalan and prednisone. After optimal dose is known, the second aim is evaluate safety and tolerance of V-MP plan, in respond terms, in a cohort of 60 patients. Finally, the entire results will be compared with those obtained from a series of 100 patients, all of them over 70 years old, diagnosed of Multiple Myeloma belonging to the GEM protocol finished in May 2003

Study Overview

Status

Completed

Conditions

Multiple Myeloma

Intervention / Treatment

Detailed Description

Multiple Myeloma is a neoplastic disorder of the last maturation stage of B cell, called plasmatic cell. It represents the second most common haematological neoplasia, after Non Hodgkin Lymphoma. The annual incidence is over 4 cases per 100.000. Multiple Myeloma is an invariably mortal disease. When illness advances, the reduction of infections resistance, the intense bones destruction (with bone pain, pathological fractures and hypercalcemia), anaemia, renal failure and, in a less frequency, neurological complications and hyperviscosity provoke severe morbidity and mortality. Five-year survival rate in patients with Multiple Myeloma treated with conventional chemotherapy is 29%. There is an urgent need of new therapeutic agents for the treatment of this disease

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - Barcelona, Spain
    - Hospital de La Santa Creu i Sant Pau
  - Barcelona, Spain
    - Hospital Clinic
  - Barcelona, Spain
    - Hospital Germans Trías i Pujol
  - Leon, Spain
    - Hospital Virgen Blanca de León
  - Madrid, Spain
    - Hospital Ramon y Cajal
  - Madrid, Spain
    - Hospital Clínico San Carlos de Madrid
  - Madrid, Spain
    - Hospital Doce de Octubre
  - Madrid, Spain
    - Hospital Universitario de La Princesa
  - Murcia, Spain
    - Hospital Morales Messeguer
  - Salamanca, Spain
    - Hospital Clinico Universitario de Salamanca
  - Segovia, Spain
    - Hospital General de Segovia
  - Valencia, Spain
    - Hospital Universitario Dr. Peset
  - Valencia, Spain
    - Hospital La Fe
  - Valencia, Spain
    - Hospital Clinic
  - Zaragoza, Spain
    - Hospital Clinico Lozano Blesa
- Asturias
  - Oviedo, Asturias, Spain
    - Hospital Central de Asturias
- Islas Canarias
  - Tenerife, Islas Canarias, Spain
    - Hospital Universitario de Canarias
- Mallorca
  - Palma de Mallorca, Mallorca, Spain
    - Hospital Son Llatzer
- Navarra
  - Pamplona, Navarra, Spain
    - Clinica Universitaria de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Age over 65 years.
Patient recently diagnosed with symptomatic Multiple Myeloma based on standard criteria and that has not received any previous chemotherapy treatment for Multiple Myeloma.
Patient has measurable disease, defined as follows:

For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value and, where applicable, urine light-chain excretion of ≥ 200 mg/24 hours.

For oligo or non-secretory multiple myeloma, measurable disease is defined by the presence of soft tissue (not bone) plasmacytomas as determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with oligo-secretory multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessment. In patients with non-secretory multiple myeloma, there is no M-protein in serum or urine.

Patient has a Karnofsky performance status higher 60%.
Patient has a life-expectancy >3 months.
Patient has the following laboratory values within 14 days before Baseline visit (Day 1 of Cycle 1, before study drug administration:

Platelet count ≥ 100x109/L, hemoglobin ≥ 8 g/dl and absolute neutrophil count (ANC) ≥ 1.0x109/L.

Corrected serum calcium < 14mg/dl. Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal. Alanine transaminase (ALT): ): ≤ 2.5 x the upper limit of normal. Total bilirubin: ≤1.5 x the upper limit of normal. Serum creatinine value ≤ 2mg/dl.

Exclusion Criteria:

Patient previously received treatment with Velcade.
Patient previously received treatment for Multiple Myeloma.
Patient had major surgery within 4 weeks before enrollment.
Patient has a platelet count < 100 x 109/L within 14 days before enrollment.
Patient has an absolute neutrophil count < 1.0 x 109/L within 14 days before.
Patient has < Grade 2 peripheral neuropathy within 14 days before enrollment.
Patient has hypersensitivity to bortezomib, boron or mannitol.
Patient has received other investigational drugs within 14 days before enrollment.
Patient is known to be seropositive for the human immunodeficiency virus (HIV), Hepatitis B surface antigen-positive or active hepatitis C infection.
Patient had a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.

Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determinate the efficacy of combination velcade, melphalan, prednisone Time Frame: 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Assess safety and tolerability Time Frame: 1 year	1 year
Assess potential superiority of this regimen versus historical controls with melphalan and prednisone alone Time Frame: 2 years	2 years
Evaluate efficacy in terms of progression-free survival and overall survival Time Frame: 5 years	5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Collaborators

Millennium Pharmaceuticals, Inc.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Chair: San Miguel Jesús, Professor, Hospital Clinico Universitario de Salamanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Spanish association of Haematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria