Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-31 @ 11:25 PM
Study NCT ID:
NCT00792506
Status:
TERMINATED
Last Update Posted:
2022-02-02
First Post:
2008-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Clinical Trial of ITF2357 In Patients With Relapsed/Refractory Multiple Myeloma
Sponsor:
Italfarmaco
Organization:
Study Overview
Official Title:
Phase II High Pulse Dose Clinical Trial of Orally Administered ITF2357 In Patients With Relapsed/Refractory Multiple Myeloma
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was prematurely discontinued for lack of recruitement.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
This is open label, phase IIa High Pulse Dose Clinical Trial testing ITF2357 (orally administered) in adult patients with relapsing/refractory multiple myeloma after at least 2 previous lines of treatment.
Patients are planned to receive ITF2357 in accordance with following scheme:
Weeks 1-6
Patient #01 is planned to receive ITF 2357 at 400 mg in one single dose on day 1, 8, 15, 22, 29 and 36. Safety assessments are planned to be performed twice a week. If no issue (grade \>3 neutropenia or any other grade ≥3 toxicity) emerges at day 15, two further patients (#02 and #03) will be enrolled and receive the same dose. If patients #02 and #03 show a favourable safety profile at day 15, and in the meantime no safety concerns arise from patient #01, the further patients will be enrolled and treated according to the below reported scheme:
* 8 more patients (#04-11) will receive 400 mg once weekly; safety assessments will be performed weekly.
* 1 patient (#12) will receive 600 mg once weekly; safety assessments will be performed twice a week.
If no safety concern emerges from patient 12 at day 15, two further patients (#13 and #14) will be enrolled and treated with 600 mg once weekly. If patients #13 and #14 don't show relevant safety concerns (grade \>3 neutropenia or any other grade ≥3 toxicity) at day 15, and in the meanwhile patient #12 maintains a favourable safety profile, eight further patients (#15-22) will be recruited and receive the same treatment regimen.
If grade \>3 neutropenia or any other grade ≥3 toxicity appear at any time during week 1-6, the treatment will be permanently discontinued.
In this phase, treatment will be administered on an inpatient basis.
Weeks 7-12
For patients still on therapy at day 43 visit, M protein will be quantified and the treatment continued or possibly modified as follows on the basis of this parameter:
Decrease \>or= of 25%:
patients in 400/week group continue 400mg for 6 further weeks patients in 600/week group continue 600mg for 6 further weeks
Stable +or- of 25%:
patients in 400/week group increase to 600mg and continue for 6 further weeks patients in 600/week group add dexamethasone 40mg for 4 days/week (day 1-4) and continue 600mg for 6 further weeks
Increase \> of 25%:
patients in 400/week group add dexamethasone 40mg for 4 days/week (day 1-4) and continue 400mg for 6 further weeks patients in 600/week group failure:out of the study patients in 600/week group
Safety assessments will be performed at weekly intervals. In case of grade \>3 neutropenia or any other grade ≥3 toxicity the treatment will be permanently discontinued.
In this phase treatment will be administered on an inpatient basis.
Weeks 13-18
For patients still on therapy at day 85 (week 13, day 1), the response rate will be quantified according to EBMT criteria. In case of response (complete, partial or minimal) or stable disease (no change) the treatment will be prolonged until week 18, whereas in case of disease progression the patient will leave the study. A new complete efficacy evaluation will be performed at day 127 (end of treatment).
During this phase safety will be assessed at weekly intervals and in case of grade \>3 neutropenia or any other grade ≥3 toxicity the treatment will be permanently discontinued.
This phase of the study will be conducted on an outpatient basis.
No dosage modification or temporary discontinuation is admitted.
Only one patient has been enrolled. The drug was ineffective in determining an improvement of the patient's disease status according to the EBMT response criteria.The study was prematurely discontinued for lack of recruitment.No firm conclusion on the safety and efficacy of ITF2357 administered at high (400 or 600 mg) single weekly doses can be drawn from the data collected from the only one patient recruited.
Patients are planned to receive ITF2357 in accordance with following scheme:
Weeks 1-6
Patient #01 is planned to receive ITF 2357 at 400 mg in one single dose on day 1, 8, 15, 22, 29 and 36. Safety assessments are planned to be performed twice a week. If no issue (grade \>3 neutropenia or any other grade ≥3 toxicity) emerges at day 15, two further patients (#02 and #03) will be enrolled and receive the same dose. If patients #02 and #03 show a favourable safety profile at day 15, and in the meantime no safety concerns arise from patient #01, the further patients will be enrolled and treated according to the below reported scheme:
* 8 more patients (#04-11) will receive 400 mg once weekly; safety assessments will be performed weekly.
* 1 patient (#12) will receive 600 mg once weekly; safety assessments will be performed twice a week.
If no safety concern emerges from patient 12 at day 15, two further patients (#13 and #14) will be enrolled and treated with 600 mg once weekly. If patients #13 and #14 don't show relevant safety concerns (grade \>3 neutropenia or any other grade ≥3 toxicity) at day 15, and in the meanwhile patient #12 maintains a favourable safety profile, eight further patients (#15-22) will be recruited and receive the same treatment regimen.
If grade \>3 neutropenia or any other grade ≥3 toxicity appear at any time during week 1-6, the treatment will be permanently discontinued.
In this phase, treatment will be administered on an inpatient basis.
Weeks 7-12
For patients still on therapy at day 43 visit, M protein will be quantified and the treatment continued or possibly modified as follows on the basis of this parameter:
Decrease \>or= of 25%:
patients in 400/week group continue 400mg for 6 further weeks patients in 600/week group continue 600mg for 6 further weeks
Stable +or- of 25%:
patients in 400/week group increase to 600mg and continue for 6 further weeks patients in 600/week group add dexamethasone 40mg for 4 days/week (day 1-4) and continue 600mg for 6 further weeks
Increase \> of 25%:
patients in 400/week group add dexamethasone 40mg for 4 days/week (day 1-4) and continue 400mg for 6 further weeks patients in 600/week group failure:out of the study patients in 600/week group
Safety assessments will be performed at weekly intervals. In case of grade \>3 neutropenia or any other grade ≥3 toxicity the treatment will be permanently discontinued.
In this phase treatment will be administered on an inpatient basis.
Weeks 13-18
For patients still on therapy at day 85 (week 13, day 1), the response rate will be quantified according to EBMT criteria. In case of response (complete, partial or minimal) or stable disease (no change) the treatment will be prolonged until week 18, whereas in case of disease progression the patient will leave the study. A new complete efficacy evaluation will be performed at day 127 (end of treatment).
During this phase safety will be assessed at weekly intervals and in case of grade \>3 neutropenia or any other grade ≥3 toxicity the treatment will be permanently discontinued.
This phase of the study will be conducted on an outpatient basis.
No dosage modification or temporary discontinuation is admitted.
Only one patient has been enrolled. The drug was ineffective in determining an improvement of the patient's disease status according to the EBMT response criteria.The study was prematurely discontinued for lack of recruitment.No firm conclusion on the safety and efficacy of ITF2357 administered at high (400 or 600 mg) single weekly doses can be drawn from the data collected from the only one patient recruited.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2008-001416-20 | EUDRACT_NUMBER | None | View |