Multiple Myeloma Clinical Trial
— MPTDOfficial title:
A Phase I/II, Multi-Center, Open Label Study of Melphalan, Prednisone, Thalidomide and Defibrotide in Advanced and Refractory Multiple Myeloma Patients
Verified date | May 2016 |
Source | University of Turin, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
This study will evaluate the safety and the efficacy of the association of Melphalan/ Prednisone/Thalidomide/Defibrotide (MPTD) as salvage treatment in advanced and refractory myeloma patients. This association might further increase the response rate achieved by oral MPT regimen
Status | Completed |
Enrollment | 24 |
Est. completion date | April 2014 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Each patient must meet all of the following inclusion criteria to be enrolled in the study: - 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.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 (see Section 13.2). - Patient is relapsed after one line of treatment but less than three lines, including high-dose chemotherapy with stem cell support, conventional poli-chemotherapy, thalidomide- and melphalan-based regimens - Patient with primary refractory disease will be considered not eligible - 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 =90 x 109/L without transfusion support within 7 days before the test. - Absolute neutrophil count (ANC) = 1.00 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: Patients meeting any of the following exclusion criteria are not to be enrolled in the study. - Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. - Pregnant or beast feeding females. - Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. - Use of any other concomitant standard/experimental anti-myeloma drug or therapy - Known positive for HIV or active infectious hepatitis, type B or C - Other concurrent anticoagulation treatment |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Dip. Scienze Mediche & IRCAD-Università, UDA Ematologia | Novara | |
Italy | Policlinico Monteluce, Clinica Medica I | Perugia | |
Italy | Divisione Di Ematologia, Ospedali Riuniti | Reggio Calabria | |
Italy | Servizio di Ematologia, Azienda Ospedaliera S. Maria Nuova | Reggio Emilia | |
Italy | Div. Univ. Di Ematologia, Az. Osp. San Giovanni Battista | Torino | TO |
Lead Sponsor | Collaborator |
---|---|
Silvio Aime |
Italy,
Alexanian R, Barlogie B, Tucker S. VAD-based regimens as primary treatment for multiple myeloma. Am J Hematol. 1990 Feb;33(2):86-9. — View Citation
Bladé J, Samson D, Reece D, Apperley J, Björkstrand B, Gahrton G, Gertz M, Giralt S, Jagannath S, Vesole D. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol. 1998 Sep;102(5):1115-23. — View Citation
Buzaid AC, Durie BG. Management of refractory myeloma: a review. J Clin Oncol. 1988 May;6(5):889-905. Review. — View Citation
McKean-Cowdin R, Feigelson HS, Ross RK, Pike MC, Henderson BE. Declining cancer rates in the 1990s. J Clin Oncol. 2000 Jun;18(11):2258-68. — View Citation
Palumbo A, Bertola A, Falco P, Rosato R, Cavallo F, Giaccone L, Bringhen S, Musto P, Pregno P, Caravita T, Ciccone G, Boccadoro M. Efficacy of low-dose thalidomide and dexamethasone as first salvage regimen in multiple myeloma. Hematol J. 2004;5(4):318-24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The safety will be assessed by showing DLT and maximum tolerated dose (MTD) of defibrotide when administered in combination with MPT | The DLT is defined by the development of febrile neutropenia, or Grade 4 neutropenia >= a week, or Grade 4 hematologic toxicity except neutropenia, or any >= Grade 3 non-hematologic toxicity considered by investigators to be related to study drug(s) in >30% of pts. MTD: maximum tolerated dose |
7 months | Yes |
Primary | The efficacy will be assessed by showing at least 55% of patients in a minimal response (MR) or at least 10 % of pts in near complete remission (nCR). | 7 months | Yes | |
Secondary | prolongation of progression-free survival | it will be evaluated from the date of enrolling until the date of first documented evidence of the end point. | Yes | |
Secondary | duration of progression-free survival | it will be evaluated from the date of enrolling until the date of first documented evidence of the end point. | Yes | |
Secondary | prolongs overall survival | it will be evaluated from the date of enrolling until the date of first documented evidence of the end point. | Yes |
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