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

NCT00358020 | Completed Phase 2

• 2 other identifiers: X05141MPTV
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

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.

Conditions

Multiple Myeloma

Keywords

MYELOMA, THALIDOMIDE, BORTEZOMIB

Outcome Measures

Primary Outcomes (1)

• SAFETY AND EFFICACY

Secondary Outcomes (1)

• PROGRESSION FREE SURVIVAL AND OVERALL SURVIVAL

Interventions

THALIDOMIDE DRUG

BORTEZOMIB DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (7)

Divisione Di Ematologia, Ospedale Centrale

Bolzano, BOLZANO, Italy

Location

Unità Operativa Complessa Di Ematologia, Presidio Ospedaliero Dell'Annunziata, Azienda Ospedaliera Di Cosenza

Cosenza, COSENZA, Italy

Location

Divisione Di Ematologia E Trapianto Di Midollo Osseo, Azienda Ospedaliera Cervello

Palermo, PALERMO, Italy

Location

Divisione Di Ematologia, Ospedali Riuniti

Reggio Calabria, Reggio Calabria, Italy

Location

Cattedra E Divisione Di Ematologia, Università Tor Vergata, Ospedale S.Eugenio

Roma, ROMA, Italy

Location

Divisione Universitaria Ematologia - Az.Osp. San Giovanni Battista

Torino, TORINO, 10126, Italy

Location

Ematologia, Azienda Ospedaliera S.Giovanni Battista

Torino, TORINO, 10126, Italy

Location

Related Publications (5)

• 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.

  PMID: 2452861 BACKGROUND

• 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.

  PMID: 11325646 BACKGROUND

• 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.

  PMID: 14586481 BACKGROUND

• 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.

  PMID: 12826635 BACKGROUND

• 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.

  PMID: 12969978 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Thalidomide; Bortezomib

Condition Hierarchy (Ancestors)

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)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines

Study Officials

• MARIO BOCCADORO, MD

  DIVISIONE DI EMATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY

  PRINCIPAL INVESTIGATOR

• ANTONIO PALUMBO, MD

  DIVISONE DI MEATOLOGIA DELL'UNIVERSITA' DI TORINO, AZIENDA OSPEDALIERA SAN GIOVANNI BATTISTA, TORINO, ITALY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2006
• First Posted: July 28, 2006
• Study Start: November 1, 2004
• Study Completion: December 1, 2008
• Last Updated: December 4, 2006

Record last verified: 2006-11

Locations

IT (7)