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

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ClinicalTrials.gov Identifier: NCT00358020

Recruitment Status : Completed

First Posted : July 28, 2006

Last Update Posted : December 4, 2006

Sponsor:

Information provided by:

University of Turin, Italy

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.

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: THALIDOMIDE Drug: BORTEZOMIB	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	30 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	November 2004
Study Completion Date :	December 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Multiple myeloma

MedlinePlus related topics: Multiple Myeloma Steroids

Drug Information available for: Thalidomide Bortezomib

Genetic and Rare Diseases Information Center resources: Multiple Myeloma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

SAFETY AND EFFICACY

Secondary Outcome Measures :

PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358020

Locations

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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

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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:

Buzaid AC, Durie BG. Management of refractory myeloma: a review. J Clin Oncol. 1988 May;6(5):889-905. Review.

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.

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.

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.

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. Epub 2003 Sep 11. Review.

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ClinicalTrials.gov Identifier:	NCT00358020
Other Study ID Numbers:	X05141 MPTV
First Posted:	July 28, 2006 Key Record Dates
Last Update Posted:	December 4, 2006
Last Verified:	November 2006

Keywords provided by University of Turin, Italy:


MYELOMA, THALIDOMIDE, BORTEZOMIB

Additional relevant MeSH terms:

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

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