Phase II High Pulse Dose Clinical Trial of Orally Administered ITF 2357 In Patients with Relapsed/Refractory Multiple Myeloma - ND

• Conditions: Patients with Relapsed/Refractory Multiple Myeloma; MedDRA version: 9.1Level: HLTClassification code 10028229Term: Multiple myelomas

• Registration Number: EUCTR2008-001416-20-IT
• Lead Sponsor: ITALFARMACO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1.Established diagnosis of multiple myeloma according to International Myeloma Working Group diagnostic criteria
2.Age ≥ 18 years
3.Patient relapsed after at least 2 lines of conventional chemotherapy or high dose therapy with autologous or allogeneic stem cell support, and/or for whom no alternative treatments are available/suitable
4.Increasing trend of monoclonal immunoglobulin or Bence-Jones proteinuria through the last 4 consecutive pre-screening measurements, already available in the patient history
5.No chemotherapy or other investigational anticancer therapy for at least 3 weeks before the start of the study
6.Full recovery from previous toxicities
7.ECOG performance status 0-2
8.Adequate bone marrow reserve: absolute neutrophil count ≥ 1000/ml; platelet count ≥ 90000/ml
9.Adequate liver function: total bilirubin within normal institutional limits (PI center); AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper limit of normal (PI center)
10.Adequate renal function: Creatinine ≤ 2.5 mg/dl or creatinine clearance ≥ 50 ml/min
11.Either men or women, accepting to practice effective contraception during the entire study period unless documentation of infertility exists. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should immediately inform her treating physician; in this case ITF 2357 treatment will be promptly discontinued
12.Able to understand and willing to sign the informed consent form.
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

1.Planned autologous or allogeneic bone marrow transplantation within 4 weeks of the initiation of ITF 2357 administration
2.Concurrent use of medicines that would confound the interpretation of toxicities and anti-tumour activity of ITF 2357 (i.e. quinolons, macrolides, 5-HT3 antagonists except for palonosetron,)
3.Clinically significant illness including, but not limited to, the following: active infection, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, cardiac arrhythmia (present or documented in the past, of any kind), any other condition (including laboratory abnormalities) that in the opinion of the Investigator places the patient to unacceptable risk for adverse outcome if he/she were to participate in the study
4.Psychiatric illness/social situations that would limit compliance with study medication and protocol requirements
5.Pregnant or lactating women
6.Positive blood tests for HIV, HBV, HCV, active EBV and CMV
7.Diseases related to active viral infections
8.Patients with a marked baseline prolongation of QTc interval (e.g. repeated demonstration of a QTc interval >440 ms for men and >450 ms for women)
9.Patients with history of additional risk factors for Torsade de Pointes (e.g. heart failure, family history of Long QT Syndrome).
10.The use of concomitant medications with potential risk of Torsade de Pointes and/or that can prolong QTc interval

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety of ITF 2357 administered once weekly at high pulse dose in patients with relapsing/refractory multiple myeloma.;Secondary Objective: 1. To evaluate the anti-tumour activity of ITF 2357 administered once weekly at high pulse dose in patients with advanced multiple myeloma, measured as decrease of M protein.<br>2. To assess the therapeutic response to ITF3257 according to EBMT criteria. <br>3. To determine pharmacokinetic profile of ITF 2357 administered following high pulse dose schedule.;Primary end point(s): The primary endpoint of the study is to assess the safety of ITF 2357 administered once weekly at high pulse dose in patients with relapsing/refractory multiple myeloma. Patients who do not show grade &#8805;3 toxicity will be counted as safety responders.