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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
THALIDOMIDE
BORTEZOMIB
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring MYELOMA, THALIDOMIDE, BORTEZOMIB

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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

Sites / Locations

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

Outcomes

Primary Outcome Measures

SAFETY AND EFFICACY

Secondary Outcome Measures

PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL

Full Information

First Posted
July 27, 2006
Last Updated
November 30, 2006
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT00358020
Brief Title
Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients
Official Title
A Phase II, Multi-Center, Open Label Study Of Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Turin, Italy

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
MYELOMA, THALIDOMIDE, BORTEZOMIB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
THALIDOMIDE
Intervention Type
Drug
Intervention Name(s)
BORTEZOMIB
Primary Outcome Measure Information:
Title
SAFETY AND EFFICACY
Secondary Outcome Measure Information:
Title
PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIO BOCCADORO, MD
Organizational Affiliation
DIVISIONE DI EMATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
ANTONIO PALUMBO, MD
Organizational Affiliation
DIVISONE DI MEATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY
Official's Role
Study Director
Facility Information:
Facility Name
Divisione Di Ematologia, Ospedale Centrale
City
Bolzano
Country
Italy
Facility Name
Unità Operativa Complessa Di Ematologia, Presidio Ospedaliero Dell'Annunziata, Azienda Ospedaliera Di Cosenza
City
Cosenza
Country
Italy
Facility Name
Divisione Di Ematologia E Trapianto Di Midollo Osseo, Azienda Ospedaliera Cervello
City
Palermo
Country
Italy
Facility Name
Divisione Di Ematologia, Ospedali Riuniti
City
Reggio Calabria
Country
Italy
Facility Name
Cattedra E Divisione Di Ematologia, Università Tor Vergata, Ospedale S.Eugenio
City
Roma
Country
Italy
Facility Name
Divisione Universitaria Ematologia - Az.Osp. San Giovanni Battista
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ematologia, Azienda Ospedaliera S.Giovanni Battista
City
Torino
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
2452861
Citation
Buzaid AC, Durie BG. Management of refractory myeloma: a review. J Clin Oncol. 1988 May;6(5):889-905. doi: 10.1200/JCO.1988.6.5.889.
Results Reference
background
PubMed Identifier
11325646
Citation
Palumbo A, Giaccone L, Bertola A, Pregno P, Bringhen S, Rus C, Triolo S, Gallo E, Pileri A, Boccadoro M. Low-dose thalidomide plus dexamethasone is an effective salvage therapy for advanced myeloma. Haematologica. 2001 Apr;86(4):399-403.
Results Reference
background
PubMed Identifier
14586481
Citation
Palumbo A, Bringhen S, Bertola A, Cavallo F, Falco P, Massaia M, Bruno B, Rus C, Barbui A, Caravita T, Musto P, Pescosta N, Rossini F, Vignetti M, Boccadoro M. Multiple myeloma: comparison of two dose-intensive melphalan regimens (100 vs 200 mg/m(2)). Leukemia. 2004 Jan;18(1):133-8. doi: 10.1038/sj.leu.2403196.
Results Reference
background
PubMed Identifier
12826635
Citation
Richardson PG, Barlogie B, Berenson J, Singhal S, Jagannath S, Irwin D, Rajkumar SV, Srkalovic G, Alsina M, Alexanian R, Siegel D, Orlowski RZ, Kuter D, Limentani SA, Lee S, Hideshima T, Esseltine DL, Kauffman M, Adams J, Schenkein DP, Anderson KC. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med. 2003 Jun 26;348(26):2609-17. doi: 10.1056/NEJMoa030288.
Results Reference
background
PubMed Identifier
12969978
Citation
Barlogie B, Shaughnessy J, Tricot G, Jacobson J, Zangari M, Anaissie E, Walker R, Crowley J. Treatment of multiple myeloma. Blood. 2004 Jan 1;103(1):20-32. doi: 10.1182/blood-2003-04-1045. Epub 2003 Sep 11.
Results Reference
background

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

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