NCT01857115

Study of Weekly Carfilzomib, Cyclophosphamide and Dexamethasone In Newly Diagnosed Multiple Myeloma Patients (wCCyd)

A MULTICENTER, OPEN LABEL STUDY OF WEEKLY CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE (wCCyd) IN NEWLY DIAGNOSED MULTIPLE MYELOMA (MM) PATIENTS

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: European Myeloma Network B.V. · Network
• Sex: All
• Age: 65 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This protocol is a phase I/II multicenter study designed to assess the safety and the efficacy of the proposed combinations as up-front treatment in elderly Multiple Myeloma (MM) patients.

Detailed description

TREATMENT PERIOD Patients will start the induction treatment with wCCyd, as soon as the screening visits of the pre-treatment period have been terminated. Each cycle will be repeated every 28 days for a total of 9 courses. Treatment schedule for 9 cycles of induction: Phase I: In the phase I part of the study, the following dose levels of carfilzomib will be studied with constant doses of dexamethasone and cyclophosphamide to define the maximum tolerated dose (MTD): Level -1 1. Cyclophosphamide given orally at the dose of 300 mg/m2 on days 1, 8, 15. 2. Dexamethasone given orally at the dose of 40 mg on days 1, 8, 15, 22 or 20 mg on days 1-2, 8-9,15-16, 22-23. 3. Carfilzomib given 20 mg/m2 IV once daily on Day 1 of Cycle 1 only followed by 36 mg/m2 on days 8, 15 of Cycle 1, then for all subsequent doses 36 mg/m2 IV once daily on days 1, 8, 15, followed by 14-day rest period (day 16 through 28). Level 0 (starting dose) 1. Cyclophosphamide given orally at the dose of 300 mg/m2 on days 1, 8, 15. 2. Dexamethasone given orally at the dose of 40 mg on days 1, 8, 15, 22 or 20 mg on days 1-2, 8-9,15-16, 22-23. 3. Carfilzomib given 20 mg/m2 IV once daily on Day 1 of Cycle 1 only followed by 45 mg/m2 on days 8, 15 of Cycle 1, then for all subsequent doses 45 mg/m2 IV once daily on days 1, 8, 15, followed by 14-day rest period (day 16 through 28). Level +1 1. Cyclophosphamide given orally at the dose of 300 mg/m2 on days 1, 8, 15. 2. Dexamethasone given orally at the dose of 40 mg on days 1, 8, 15, 22 or 20 mg on days 1-2, 8-9,15-16, 22-23. 3. Carfilzomib given 20 mg/m2 IV once daily on Day 1 of Cycle 1 only followed by 56 mg/m2 on days 8, 15 of Cycle 1, then for all subsequent doses 56 mg/m2 IV once daily on days 1, 8, 15, followed by 14-day rest period (day 16 through 28). Level +2 1. Cyclophosphamide given orally at the dose of 300 mg/m2 on days 1, 8, 15. 2. Dexamethasone given orally at the dose of 40 mg on days 1, 8, 15, 22 or 20 mg on days 1-2, 8-9,15-16, 22-23. 3. Carfilzomib given 20 mg/m2 IV once daily on Day 1 of Cycle 1 only followed by 70 mg/m2 on days 8, 15 of Cycle 1, then for all subsequent doses 70 mg/m2 IV once daily on days 1, 8, 15, followed by 14-day rest period (day 16 through 28). Patients will be observed during the first cycle of therapy for the assessment of side effects and observation of DLTs. Dose escalation will proceed as follows: * 3 patients will be entered at dose level 0. * If 0/3 patients experience DLT, dose escalation will continue. * If 1/3 patients experience DLT, 3 additional patients will be added to this cohort (max 6). * If no further patients experience DLT (1/6) dose escalation will continue. * If 2/6 patients experience DLT, the MTD will have been exceeded and the MTD will be the previous dose at which \< 2/6 experienced DLT. * If 2/3 patients experience a DLT at any given dose, the MTD will have been exceeded and the MTD will be the preceding dose at which \< 2/6 (or 1/3) patients experienced a DLT. Phase II: The dose used to treat patients in the phase II will be the MTD defined in the phase I of the study. MAINTENANCE PERIOD At the end of the induction phase, patients will start the maintenance phase with Carfilzomib at the MTD defined by the phase I study IV once daily on days 1, 8, 15 until progression or intolerance. Treatment schedule for maintenance until progression or intolerance: Carfilzomib at the MTD defined by phase I study IV once daily on days 1, 8, 15.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Carfilzomib
DRUG	Cyclophosphamide
DRUG	Dexamethasone

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-11-01
• Completion: 2024-09-01
• First posted: 2013-05-20
• Last updated: 2024-11-13

Locations

1 site across 1 country: Italy