Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients

November 30, 2006 updated by: University of Turin, Italy

A Phase II, Multi-Center, Open Label Study Of Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients

The purpose of this study is to evaluate the safety and the efficacy of the association of Melphalan/Prednisone/Thalidomide/VELCADE (MPTV) as salvage treatment in advanced and refractory myeloma patients. This association might further increase the response rate achieved by the standard oral MP regimen.

Study Overview

Status

Completed

Conditions

Multiple Myeloma

Intervention / Treatment

Detailed Description

In Multiple Myeloma (MM) patients, the conventional treatment is the oral combination melphalan and prednisone (MP). thalidomide has been widely used in myeloma, it has been proved clinical effective in refractory myeloma patients, it acts sinergistically in association with dexamethasone. In newly diagnosed patients, the combination oral MP plus thalidomide increased the partial and complete response rate.Bortezomib represents a novel class of anti-cancer drugs, it is active in patient with multiple myeloma who are refractory to conventional chemotherapy. In a preliminary report, the combination of VELCADE and Thalidomide induced a remarkable 60% PR rate in advanced refractory myeloma patients. This study will evaluate the safety and the efficacy of the association of Melphalan/ Prednisone/Thalidomide/VELCADE (MPTV) as salvage treatment in advanced and refractory myeloma patients. This association might further increase the response rate achieved by the standard oral MP regimen.

Study Type

Interventional

Enrollment

Phase

Phase 2

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

Italy
- - Bolzano, Italy
    - Divisione Di Ematologia, Ospedale Centrale
  - Cosenza, Italy
    - Unità Operativa Complessa Di Ematologia, Presidio Ospedaliero Dell'Annunziata, Azienda Ospedaliera Di Cosenza
  - Palermo, Italy
    - Divisione Di Ematologia E Trapianto Di Midollo Osseo, Azienda Ospedaliera Cervello
  - Reggio Calabria, Italy
    - Divisione Di Ematologia, Ospedali Riuniti
  - Roma, Italy
    - Cattedra E Divisione Di Ematologia, Università Tor Vergata, Ospedale S.Eugenio
  - Torino, Italy, 10126
    - Divisione Universitaria Ematologia - Az.Osp. San Giovanni Battista
  - Torino, Italy, 10126
    - Ematologia, Azienda Ospedaliera S.Giovanni Battista

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient is of a legally consenting age as defined by local regulations.
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.
Female patient is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) for the duration of the study.
Patient was previously diagnosed with multiple myeloma based on standard criteria.
Patient is relapsed or refractory after one or two lines of treatment including high-dose chemotherapy with stem cell support, conventional poli-chemotherapy, thalidomide- and melphalan-based regimens.
Patient has measurable disease, defined as follows: any quantifiable serum monoclonal protein value (generally, but not necessarily, greater than 1 g/dL of IgG M-Protein and greater than 0.5 g/dL of IgA M-Protein) and, where applicable, urine light-chain excretion of >200 mg/24 hours.
Patient has a Karnofsky performance status ≥60%.
Patient has a life-expectancy >3 months.
Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cycle 1, before study drug administration):
Platelet count ≥75 x 109/L without transfusion support within 7 days before the test.
Absolute neutrophil count (ANC) ≥ 0.75 x 109/L without the use of growth factors.
Corrected serum calcium ≤14 mg/dL (3.5 mmol/L).
Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal (ULN).
Alanine transaminase (AST): ≤ 2.5 x the ULN.
Total bilirubin: ≤ 1.5 x the ULN.
Calculated or measured creatinine clearance: ≥20 mL/minute.

Exclusion Criteria:

Patient has an absolute neutrophil count <0.75 × 109/L within 14 days before enrollment.
Patient has a calculated or measured creatinine clearance <20 mL/minute within 14 days before enrollment.
Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
Patient has known hypersensitivity to bortezomib, boron, mannitol or thalidomide.

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
SAFETY AND EFFICACY

Secondary Outcome Measures

Outcome Measure
PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL

Collaborators and Investigators

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

Sponsor

University of Turin, Italy

Investigators

Principal Investigator: MARIO BOCCADORO, MD, DIVISIONE DI EMATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY
Study Director: ANTONIO PALUMBO, MD, DIVISONE DI MEATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY

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

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

November 1, 2004

Study Completion

December 1, 2008

Study Registration Dates

First Submitted

July 27, 2006

First Submitted That Met QC Criteria

July 27, 2006

First Posted (Estimate)

July 28, 2006

Study Record Updates

Last Update Posted (Estimate)

December 4, 2006

Last Update Submitted That Met QC Criteria

November 30, 2006

Last Verified

November 1, 2006

More Information

Terms related to this study

Keywords

MYELOMA, THALIDOMIDE, BORTEZOMIB

Additional Relevant MeSH Terms

Other Study ID Numbers

X05141
MPTV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.