History of Changes for Study: NCT02659293

Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma

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Study Record Versions

Version	Submitted Date	Changes
1	January 19, 2016	None (earliest Version on record)
2	May 11, 2016	Recruitment Status, Study Status and Contacts/Locations
3	November 14, 2016	Study Status
4	September 21, 2017	Study Status and Contacts/Locations
5	February 6, 2018	Study Status and Contacts/Locations
6	March 9, 2018	Outcome Measures, Arms and Interventions, Study Status and Eligibility
7	October 7, 2019	Study Status
8	September 11, 2020	Study Status
9	June 29, 2021	Recruitment Status, Study Status, Contacts/Locations and Study Design
10	April 26, 2023	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	IRB15-1286
Brief Title:	Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma
Official Title:	Phase 3 Randomized Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma
Secondary IDs:

Study Status


Record Verification:	January 2016
Overall Status:	Not yet recruiting
Study Start:	March 2016
Primary Completion:	January 2018 [Anticipated]
Study Completion:

First Submitted:	January 15, 2016
First Submitted that Met QC Criteria:	January 19, 2016
First Posted:	January 20, 2016 [Estimate]

Last Update Submitted that Met QC Criteria:	January 19, 2016
Last Update Posted:	January 20, 2016 [Estimate]

Sponsor/Collaborators


Sponsor:	University of Chicago
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description

Brief Summary:

This is a Phase 3 randomized trial of carfilzomib, lenalidomide, dexamethasone versus lenalidomide alone after stem-cell transplant for multiple myeloma, eligible to subjects who completed autologous stem cell transplant for symptomatic myeloma who are considered for lenalidomide maintenance.

Detailed Description:

Primary Objective:

To compare progression free survival between Kyprolis (Carfilzomib), Revlimid (lenalidomide), Dexamethasone (KRd) arm and lenalidomide arm

Secondary Objectives

To determine the rate of minimal residual negative disease (MRD) at 6 and 12 months after randomization
To compare the efficacy (rate of partial response, very good partial response, complete response, and stringent complete response) of KRd vs. Lenalidomide alone after randomization

Conditions


Conditions:	Multiple Myeloma
Keywords:	Multiple myeloma stem-cell transplant Symptomatic myeloma lenalidomide carfilzomib dexamethasone

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	180 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Active Comparator: Lenalidomide Arm Control arm using lenalidomide only	Drug: Lenalidomide Other Names: Revlimid
Experimental: Carfilzomib, Lenalidomide, Dexamethasone (KRd) Arm Experimental arm using a combination of Carfilzomib, Lenalidomide and Dexamethasone	Drug: Lenalidomide Other Names: Revlimid Drug: Carfilzomib Other Names: Kyprolis Drug: Dexamethasone

Outcome Measures


Primary Outcome Measures:
1.	Time to progression or death [ Time Frame: From date of first treatment until maximum 6 year post randomization ]
Secondary Outcome Measures:
1.	Rate of minimal residual negatibe disease (MRD) calculated using chi-square or Fisher's tests [ Time Frame: From date of screening up until 36 months on treatment ]
2.	Efficacy Rate of KRd arm versus lenalidomide arm [ Time Frame: From date of screening up until 36 months on treatment ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Patients who completed single autologous stem cell transplant after completion of at most 2 induction regimens (excluding dexamethasone alone) and are in at least stable disease in the first 100 days after stem cell transplantation. Patients must be within 12 months of initiation of induction therapy and must have had not more than 2 prior induction regimens. Bone marrow specimen will be required at study entry; available DNA sample will be used for calibration step for MRD evaluation by gene sequencing. Males and females ≥ 18 years of age ECOG performance status of 0-1 Adequate hepatic function, with bilirubin ≤ 1.5 x ULN and aspirate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN ANC ≥ 1.0 x 109/L, hemoglobin ≥ 8 g/dL, platelet count ≥ 75 x 109/L. Calculated creatinine clearance (by Cockcroft-Gault) ≥ 50 ml/min or serum creatinine below 2 mg/dL Females of childbearing potential (FCBP) must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to initiating lenalidomide. The first pregnancy test must be performed within 10-14 days before and the second pregnancy test must be performed within 24 hours before lenalidomide is prescribed for Cycle 1 (prescriptions must be filled within 7 days). FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. UCM IRB CRd vs. R Version 1.0 Page 11 Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy. All study participants in the US must be consented to and registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of Revlimid REMS®. Voluntary written informed consent Exclusion Criteria: Patients who completed single autologous stem cell transplant after completion of at most 2 induction regimens (excluding dexamethasone alone) and are in at least stable disease in the first 100 days after stem cell transplantation. Patients must be within 12 months of initiation of induction therapy and must have had not more than 2 prior induction regimens. Bone marrow specimen will be required at study entry; available DNA sample will be used for calibration step for MRD evaluation by gene sequencing. Males and females ≥ 18 years of age ECOG performance status of 0-1 Adequate hepatic function, with bilirubin ≤ 1.5 x ULN and aspirate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN ANC ≥ 1.0 x 109/L, hemoglobin ≥ 8 g/dL, platelet count ≥ 75 x 109/L. Calculated creatinine clearance (by Cockcroft-Gault) ≥ 50 ml/min or serum creatinine below 2 mg/dL Females of childbearing potential (FCBP) must have 2 negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to initiating lenalidomide. The first pregnancy test must be performed within 10-14 days before and the second pregnancy test must be performed within 24 hours before lenalidomide is prescribed for Cycle 1 (prescriptions must be filled within 7 days). FCBP must agree to use 2 reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. UCM IRB CRd vs. R Version 1.0 Page 11 Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy. All study participants in the US must be consented to and registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of Revlimid REMS®. Voluntary written informed consent

Contacts/Locations


Central Contact Person:	Jennifer Nam Telephone: 773-702-7716 Email: jnam@medicine.bsd.uchicago.edu
Locations:	United States, Illinois
	University of Chicago Chicago, Illinois, United States, 60637 Contact:Contact: Jennifer Nam 773-702-7716 jnam@medicine.bsd.uchicago.edu Contact:Principal Investigator: Andrzej Jakubowiak, M.D.

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