Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients (CCD)
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|ClinicalTrials.gov Identifier: NCT02204241|
Recruitment Status : Active, not recruiting
First Posted : July 30, 2014
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Carfilzomib Drug: Cyclophosphamide Drug: Dexamethasone||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open Label Phase I/II Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma (MM) Patients|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2021|
Treatment schedule for 9 cycles of induction:
Cyclophosphamide given orally at the dose of 300 mg/m2 on days 1, 8, 15. 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.
Carfilzomib given 20 mg/m2 IV once daily on Day 1-2 of Cycle 1 only followed by 36/45/56/70 mg/m2 on days 8-9, 15-16 of Cycle 1, then for all subsequent doses 36/45/56/70 mg/m2 IV once daily on days 1-2, 8-9, 15-16, followed by 12-day rest period (day 17 through 28).
Treatment schedule for maintenance until progression or intolerance:
Carfilzomib at the MTD defined by phase I study IV once daily on days 1-2, 15-16.
- Dose Limiting Toxicity (DLT) [ Time Frame: 1 year ]
- Grade 2 neuropathy with pain
- any Grade 3 tox. (excluding nausea, vomiting, diarrhea)
- Grade 3 nausea, vomiting, or diarrhea despite maximal antiemetic/antidiarrheal therapy
Grade 4 fatigue lasting for ≥ 7 days
- Any non-hematologic tox. requiring a dose reduction within Cycle 1
- Inability to receive Day 1 dose of Cycle 2 due to drug related tox. persisting from Cycle 1 or drug related tox. newly encountered on Day 1 of Cycle 2.
- Grade 4 neutropenia (ANC < 0.5 x 109/L) lasting for ≥ 7 days
- Febrile neutropenia (ANC < 1.0 x 109/L with a fever ≥ 38.3ºC)
- Grade 4 thrombocytopenia (platelets < 25.0 x 109/L) lasting ≥ 7 days despite dose delay
- Grade 3-4 thrombocytopenia associated with bleeding
- Any hematologic tox. requiring a dose reduction within Cycle 1
- Response rate (RR) [ Time Frame: 3 years ]Determine the response rate
- Progression-free survival (PFS) [ Time Frame: 3 years ]Determine the progression-free survival (PFS)
- Time to progression (TTP) [ Time Frame: 3 years ]Determine the time to progression (TTP)
- Duration of response (DOR) [ Time Frame: 3 years ]Determine the duration of response (DOR)
- Overall survival (OS) [ Time Frame: 3 years ]Determine the overall survival (OS)
- Time to next therapy (TTNT) [ Time Frame: 3 years ]Determine the time to next therapy (TTNT)
- Responses [ Time Frame: 3 years ]Determine whether responses obtained with CCyd treatment are associated with a prolongation of PFS, in comparison with non-responding patients
- Response and survival [ Time Frame: 3 years ]Determine whether tumor response and outcome may change in subgroups with different prognosis according to current prognostic factors (β2-microglobulin, C-reactive protein (CRP), FISH, gene expression profile)
- Maintenance [ Time Frame: 3 years ]Determine the benefit on PFS and OS of maintenance with carfilzomib
- Adverse event [ Time Frame: 1 years ]The toxicity is defined as the first occurrence of a grade 4 hematologic drug-related toxicity (grade 4 neutropenia must last longer than 3 days and grade 4 thrombocytopenia must last longer than 7 days in order to be considered a toxicity) excluding anemia. Assessment of adverse events will be performed at the end of third cycle according to the National Cancer Institute Common Terminology Criteria of Adverse Events (CTCAE version 4.0).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204241
|Torino, Italy, 10126|