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

This study has been completed.
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT00358020
First received: July 27, 2006
Last updated: November 30, 2006
Last verified: November 2006
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma
Drug: THALIDOMIDE
Drug: BORTEZOMIB
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multi-Center, Open Label Study Of Melphalan, Prednisone, Thalidomide And Bortezomib In Advanced And Refractory Multiple Myeloma Patients

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • SAFETY AND EFFICACY

Secondary Outcome Measures:
  • PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL

Estimated Enrollment: 30
Study Start Date: November 2004
Estimated Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358020

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

Publications:
ClinicalTrials.gov Identifier: NCT00358020     History of Changes
Other Study ID Numbers: X05141, MPTV
Study First Received: July 27, 2006
Last Updated: November 30, 2006
Health Authority: Italy: Ministry of Health

Keywords provided by University of Turin, Italy:
MYELOMA, THALIDOMIDE, BORTEZOMIB

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases
Bortezomib
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014