A MULTICENTER, OPEN-LABEL, PHASE II STUDY OF DASATINIB IN COMBINATION WITH MELPHALAN AND PREDNISONE (D-MP) IN ADVANCED, RELAPSED / REFRACTORY MULTIPLE MYELOMA PATIENTS. - D-MP

• Conditions: RELAPSED / REFRACTORY MULTIPLE MYELOMA PATIENTS; MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2008-004165-26-IT
• Lead Sponsor: FONDAZIONE NEOPLASIE SANGUE ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Age ≥ 18 years and ≤75 year
- Patient was previously diagnosed with symptomatic MM based on standard criteria, and has measurable disease, defined as follows:
- Secretory myeloma: 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;
- Non-secretory myeloma: > 30% plasma cells in the bone marrow and at least one plasmocytoma > 2 cm as determined by clinical examination or applicable radiographs (i.e., MRI or CT scan).
- Patient is relapsed or refractory and has received previous regimen containing Thalidomide or Lenalidomide and Bortezomib or even MP (patient is refractory if there is a progression during the last therapy or within 2 months after its completion).
- Patient has ≤ Grade 2 peripheral neuropathy within 28 days before enrollment and all acute toxicities from any prior therapy (radiotherapy, chemotherapy or surgical procedures) must have resolved to grade ≤ 2, according to the NCI CTCAE version 3.0 at study entry.
- Patient has the following laboratory values within 28 days before Baseline day 1 of the Cycle 1:
- Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)
- Hepatic enzymes (AST, ALT ) ≤ 2.5 times the institutional ULN
- Serum Na, K+, Mg2+, Phosphate and calcium > Lower Limit of Normal (LLN)
- Calculated or measured creatinine clearance: ≥ 20 mL/minute
- Hemoglobin, Neutrophil count, Platelets, PT, PTT, Fibrinogen all Grade 0-1
- Corrected serum calcium ≤ 14 mg/dL ( ≤ 3.5 mmol/L).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with > 2 previous treatment regimens.
- Multiple Myeloma treatment (ie, chemotherapy, biological, immunotherapy or investigational agent [therapeutic or diagnostic]) administered within 21 days prior to treatment initiation.
- Use of any other concomitant standard/experimental anti-myeloma drug or therapy
- Concurrent anticoagulation treatment or medications that directly or durably inhibit platelet function.
- Malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 year. Exceptions: basal cell or non metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or FIGO Stage 1 carcinoma of the cervix.
-Concurrent medical condition which may increase the risk of toxicity, including:
- Pleural or pericardial effusion of any grade
- Clinically significant cardiac disease (NYHA classification III and IV);

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified