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Phase II Clinical Trial of ITF2357 In Patients With Relapsed/Refractory Multiple Myeloma

NCT00792506 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-02-02

No results posted yet for this study

Summary

Primary objective:

To assess the safety of ITF 2357 administered once weekly at high pulse dose in patients with relapsing/refractory multiple myeloma.

Secondary objectives:

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.
2. To assess the therapeutic response to ITF3257 according to EBMT criteria.
3. To determine pharmacokinetic profile of ITF 2357 administered following high pulse dose schedule.

Conditions

Interventions

DRUG

ITF2357

Treatment was to be administered on an inpatient basis from week 1 to week 13 and on an outpatient basis from week 14 to anticipated end of treatment (week 18). The patients had to be hospitalized on day 1 every week. The Investigator had to administer ITF 2357 in one single dose (two or three 200 mg capsules at one time) under his/her direct control.

Sponsors & Collaborators

  • Italfarmaco

    lead INDUSTRY

Principal Investigators

  • Giorgio La Nasa, MD · Presidio Ospedaliero R. Binaghi, Cagliari - Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-01-31
Completion
2010-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00792506 on ClinicalTrials.gov