Velcade-Melphalan-Prednisone in Older Untreated Multiple Myeloma Patients.
Information source: PETHEMA Foundation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: Velcade (Drug); Melphalan (Drug); Prednisone (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: PETHEMA Foundation Official(s) and/or principal investigator(s): San Miguel Jesús, Professor, Study Chair, Affiliation: Hospital Clinico Universitario de Salamanca
Summary
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
Clinical Details
Official title: A National, Multi-Center, Open-Label Study of Velcade in Combination With Melphalan and Prednisone (V-MP) in Older Untreated Multiple Myeloma Patients.
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Determinate the efficacy of combination velcade, melphalan, prednisone
Secondary outcome: Assess safety and tolerabilityAssess potential superiority of this regimen versus historical controls with melphalan and prednisone alone Evaluate efficacy in terms of progression-free survival and overall survival
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
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Hospital ClÃnic, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Hospital Germans Trias i Pujol, Barcelona, Spain
Hospital Virgen Blanca de León, Leon, Spain
Hospital ClÃnico San Carlos de Madrid, Madrid, Spain
Hospital Doce de Octubre, Madrid, Spain
Hospital Ramón y Cajal, Madrid, Spain
Hospital Universitario de la Princesa, Madrid, Spain
Hospital Morales Messeguer, Murcia, Spain
Hospital ClÃnico Universitario de Salamanca, Salamanca, Spain
Hospital General de Segovia, Segovia, Spain
Hospital ClÃnic, Valencia, Spain
Hospital La Fe, Valencia, Spain
Hospital Universitario Dr. Peset, Valencia, Spain
Hospital ClÃnico Lozano Blesa, Zaragoza, Spain
Hospital Central de Asturias, Oviedo, Asturias, Spain
Hospital Universitario de Canarias, Tenerife, Islas Canarias, Spain
Hospital Son Llatzer, Palma de Mallorca, Mallorca, Spain
ClÃnica Universitaria de Navarra, Pamplona, Navarra, Spain
Additional Information
Spanish association of Haematology
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Starting date: April 2004
Last updated: January 8, 2011
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