Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02659293|
Recruitment Status : Active, not recruiting
First Posted : January 20, 2016
Last Update Posted : June 30, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Lenalidomide Drug: Carfilzomib Drug: Dexamethasone Drug: Lenalidomide (Control)||Phase 3|
- To compare progression free survival between Kyprolis (Carfilzomib), Revlimid (lenalidomide), Dexamethasone (KRd) arm and lenalidomide arm
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3 Randomized Trial of Carfilzomib, Lenalidomide, Dexamethasone Versus Lenalidomide Alone After Stem-cell Transplant for Multiple Myeloma|
|Actual Study Start Date :||April 26, 2016|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||November 2026|
Active Comparator: Lenalidomide (Control)
Treatment with lenalidomide only
Drug: Lenalidomide (Control)
Other Name: Revlimid
Experimental: Experimental Combination Regimen
Experimental arm using a combination of Carfilzomib, Lenalidomide and Dexamethasone
Other Name: Revlimid
Other Name: Kyprolis
- Progression free survival rates in participants receiving drug combination [ Time Frame: 4 years ]Measurement of time to disease worsening as measured by International Myeloma Working Group (IMWG) response criteria.
- Rate of minimal residual negative disease (MRD) in participants receiving drug combination [ Time Frame: 3 years ]Calculation of number of participants with MRD-negative disease.
- Response rate in participants receiving drug combination [ Time Frame: 3 years ]Number of participants with disease response (e.g. improvement) as measured by International Myeloma Working Group (IMWG) response criteria.
- Treatment-related side effects [ Time Frame: From date of screening until end of treatment ]Number of participants with grade 2 or greater treatment-related side effects as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Patients who have had more than 12 months of prior therapy. Patients outside of this window may be considered for inclusion on a case-by-case basis.
Patients who progressed after initial therapy.
- Subjects whose therapy changed due to suboptimal response, intolerance, etc., remain eligible, provided they do not meet criteria for progression.
- No more than two regimens for induction will be allowed excluding dexamethasone alone.
- Evidence of progressive disease as per International Myeloma Working Group (IMWG) criteria
- Patients who have already started or received post-transplant maintenance or consolidation regimen
- Patients not able to tolerate lenalidomide or carfilzomib or dexamethasone
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Plasma cell leukemia
- Waldenström's macroglobulinemia or IgM myeloma
- Peripheral neuropathy ≥ Grade 2 at screening
- Diarrhea > Grade 1 in the absence of antidiarrheals
- CNS involvement
- Pregnant or lactating females
- Radiotherapy within 14 days before randomization. Seven days may be considered if to single area.
- Major surgery within 3 weeks prior to first dose
- Myocardial infarction within 6 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Prior or concurrent deep vein thrombosis or pulmonary embolism
- Rate-corrected QT interval of electrocardiograph (QTc) > 470 msec on a 12-lead ECG during screening
- Uncontrolled hypertension or diabetes
- Acute infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- Non-hematologic malignancy or non-myeloma hematologic malignancy within the past 3 years except a) adequately treated basal cell, squamous cell skin cancer, thyroid cancer, carcinoma in situ of the cervix, or prostate cancer < Gleason Grade 6 with stable prostate specific antigen levels or cancer considered cured by surgical resection alone
- Any clinically significant medical disease or condition that, in the Treating Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
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): NCT02659293
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Michigan|
|Wayne State University - Karmanos Cacner Institute|
|Detroit, Michigan, United States, 48201|
|Polish Myeloma Consortium|
|Principal Investigator:||Andrzej Jakubowiak, MD, PhD||University of Chicago|
|Responsible Party:||University of Chicago|
|Other Study ID Numbers:||
|First Posted:||January 20, 2016 Key Record Dates|
|Last Update Posted:||June 30, 2021|
|Last Verified:||June 2021|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Angiogenesis Modulating Agents