Study of Daratumumab Combined With Carfilzomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04113018|
Recruitment Status : Not yet recruiting
First Posted : October 2, 2019
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||LCI-HEM-MYE-KRdD-001: Phase II Study of Daratumumab Combined With Carfilzomib, Lenalidomide and Dexamethasone in Newly Diagnosed Multiple Myeloma|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||October 2026|
|Estimated Study Completion Date :||October 2026|
Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab
Drug: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab
- Complete Response [ Time Frame: From enrollment to best response; assessed for approximately 5 years ](CR)- Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates
- Progression Free Survival (PFS) [ Time Frame: From date of treatment start to date of progression or death; assessed for approximately 5 years ]PFS is defined as duration of time from enrollment to the study to time of progression or death.
- Overall Survival (OS) [ Time Frame: From date of enrollment to date of death; assessed for approximately 5 years ]OS is defined as the duration from enrollment to the study (treatment start date) to the date of death from any cause. Subjects who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive.
- Time to Next Treatment (TTNT) [ Time Frame: assessed for approximately 5 years ]Time to next treatment (TTNT) will be calculated from the time of treatment start until the start of the first subsequent anti-cancer therapy after all protocol directed therapy is completed. For surviving subjects who do not receive subsequent therapy, TTNT will be censored at the last contact date. For subjects who die before beginning subsequent anti-cancer therapy, TTNT will be censored at the date of death.
- Duration of Response (DoR) [ Time Frame: assessed for approximately 5 years ]Duration of response (DoR) will be calculated for each subject achieving a PR or better and will be calculated from the time of the first assessment that identified response until disease progression or death
- Time to Disease Progression (TTP) [ Time Frame: From date of start of treatment to date of disease progression; assessed for approximately 5 years ]Time to disease progression (TTP) will be calculated in the same fashion as described for PFS with the exception that for subjects who die for causes other than disease progression, TTP will be censored at the date of the other cause mortality.
- Overall Response (OR) [ Time Frame: From enrollment to best response while on treatment (subjects on induction treatment for approximately 32 weeks) ]
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): NCT04113018
|Contact: Danielle Harrisemail@example.com|
|United States, North Carolina|
|Levine Cancer Institute||Not yet recruiting|
|Charlotte, North Carolina, United States, 28204|
|Principal Investigator:||Saad Usmani, MD||Atrium Health|