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Phase II High Pulse Dose Clinical Trial of Orally Administered ITF2357 In Patients With Relapsed/Refractory Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

Phase II High Pulse Dose Clinical Trial of Orally Administered ITF2357 In Patients With Relapsed/Refractory Multiple Myeloma

Multiple myeloma (MM) is a B-cell neoplasm that manifests as one or more lytic bone lesions,
monoclonal protein in the blood or urine and disease in the bone marrow (BM). The malignant
plasma cells accumulate in the BM and intricate interactions occur between the BM
microenvironment and the MM cells, frequently causing bone destruction, which in turn
stimulates tumour growth. The tumour itself, its products and the host response to it result
in the multitude of symptoms and organ dysfunction characteristic of MM, including bone
pain, renal failure, susceptibility to infections, anaemia and hypercalcemia. The median age
at diagnosis is 68 years and men are more frequently affected than women.

ITF2357 is a novel and proprietary molecule synthesized by Italfarmaco S.p.A. Research
Laboratories, provided with an established and powerful HDAC-inhibitory activity. It is
being developend for a range of possible clinical applications both in oncohaematological
conditions and in chronic inflammatory diseases. The former application is consistent with
the well known antitumor pharmacological properties of HDAC-inhibitors as a family (i.e.
cell-cycle arrest, pro-apoptotic and cell-differentiating effects); the latter application
(chronic inflammation) is based of the demonstrated anticytokine effect of ITF2357.

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

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 ≥

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.

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


Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety of ITF2357 administered once weekly at high pulse dose in patients with relapsing/refractory multiple myeloma.

Outcome Time Frame:

30 weeks

Safety Issue:


Principal Investigator

Giorgio La Nasa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Presidio Ospedaliero R. Binaghi, Cagliari - Italy


Italy: Ministry of Health

Study ID:




Start Date:

October 2008

Completion Date:

July 2010

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell