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

NCT00388635 | Completed Phase 1

• 1 other identifier: PET-VEL-2004-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 19

Brief 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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Patients over 65 years old

Outcome Measures

Primary Outcomes (1)

• Determinate the efficacy of combination velcade, melphalan, prednisone

  1 year

Secondary Outcomes (3)

• Assess safety and tolerability

  1 year

• Assess potential superiority of this regimen versus historical controls with melphalan and prednisone alone

  2 years

• Evaluate efficacy in terms of progression-free survival and overall survival

  5 years

Interventions

Velcade DRUG

Phase I: Velcade, 1.0mg/m2-1.3mg/m2 in escalating doses every 6 weeks for 4 cycles Pase II: Velcade at optimal doses, twice a week (days 1, 4, 8, 11, 22, 25, 28 and 32) follow a rest period for 10 days (days 33 to 42)

Melphalan DRUG

Melfalán 9mg/m2 days 1 to 4, V.O, follow by a rest period of 38 days in phse I and II

Prednisone DRUG

Prednisone 60mg/m2 v.o days 1 to 4 follows by a rest period of 38 days (phase I and II)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PETHEMA Foundation: lead
• Millennium Pharmaceuticals, Inc.: collaborator
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

Study Sites (19)

Hospital Clínic

Barcelona, Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, Barcelona, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

Location

Hospital Clínico San Carlos de Madrid

Madrid, Madrid, Spain

Location

Hospital Doce de Octubre

Madrid, Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Madrid, Spain

Location

Hospital Universitario de la Princesa

Madrid, Madrid, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Mallorca, Spain

Location

Hospital Morales Messeguer

Murcia, Murcia, Spain

Location

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Location

Hospital Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital Clínic

Valencia, Valencia, Spain

Location

Hospital La Fe

Valencia, Valencia, Spain

Location

Hospital Universitario Dr. Peset

Valencia, Valencia, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, Spain

Location

Hospital Virgen Blanca de León

León, Spain

Location

Hospital Clínico Universitario de Salamanca

Salamanca, Spain

Location

Hospital General de Segovia

Segovia, Spain

Location

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Related Links

• Spanish association of Haematology

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib; Melphalan; 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)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• San Miguel Jesús, Professor

  Hospital Clinico Universitario de Salamanca

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2006
• First Posted: October 17, 2006
• Study Start: April 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: December 1, 2008
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

ES (19)