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Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

Primary Purpose

Relapsed Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dexamethasone
Lenalidomide
Carfilzomib
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed Multiple Myeloma focused on measuring Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Symptomatic multiple myeloma
  2. Measurable disease, as defined by one or more of the following (assessed within 21 days prior to randomization):

    • Serum M-protein ≥ 0.5 g/dL
    • Urine Bence-Jones protein ≥ 200 mg/24 hours
    • For immunoglobulin A (IgA) patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL)
  3. Prior treatment with at least one, but no more than three, regimens for multiple myeloma
  4. Documented relapse or progressive disease on or after any regimen
  5. Achieved a response to at least one prior regimen
  6. Age ≥ 18 years
  7. Life expectancy ≥ 3 months
  8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  9. Adequate hepatic function, with serum alanine aminotransferase (ALT) ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dL (34 µmol/L) within 21 days prior to randomization
  10. Absolute neutrophil count ≥ 1.0 × 10^9/L within 21 days prior to randomization
  11. Hemoglobin ≥ 8 g/dL (80 g/L) within 21 days prior to randomization
  12. Platelet count ≥ 50 × 10^9/L (≥ 30 × 10^9/L if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization
  13. Creatinine clearance (CrCl) ≥ 50 mL/minute within 21 days prior to randomization
  14. Written informed consent in accordance with federal, local, and institutional guidelines
  15. Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception
  16. Male subjects must agree to practice contraception

Exclusion Criteria:

  1. If previously treated with bortezomib (alone or in combination), progression during treatment
  2. If previously treated with a lenalidomide and dexamethasone (len/dex) combination:

    • Progression during the first 3 months of initiating treatment
    • Any progression during treatment if the len/dex combination was the subject's most recent line of therapy
  3. Discontinuation of previous lenalidomide or dexamethasone due to intolerance; subjects intolerant to bortezomib are not excluded
  4. Prior carfilzomib treatment
  5. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  6. Waldenström's macroglobulinemia or IgM myeloma
  7. Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
  8. Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization
  9. Radiotherapy to multiple sites or immunotherapy/antibody therapy within 28 days prior to randomization; localized radiotherapy to a single site within 7 days prior to randomization
  10. Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization
  11. Pregnant or lactating females
  12. Major surgery within 21 days prior to randomization
  13. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomization
  14. Known human immunodeficiency virus infection
  15. Active hepatitis B or C infection
  16. Myocardial infarction within 4 months prior to randomization, New York Hear Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
  17. Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization
  18. Other malignancy, including myelodysplastic syndromes (MDS), within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
  19. Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization
  20. Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
  21. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
  22. Ongoing graft-vs-host disease
  23. Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization
  24. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

Sites / Locations

  • Mayo Clinic
  • Providence St. Joseph Medical Center
  • St. Jude Hospital Yorba Linda dba; St. Joseph Heritage Healthcare
  • Stanford University
  • Colorado Blood Cancer Institute
  • Cancer and Blood Disease Center
  • Rush University Medical Center
  • Indiana University Health Melvin and Bren Simon Cancer Center
  • University of Kansas Cancer Center
  • The University of Michigan - Comprehensive Cancer Center
  • Mayo Clinic
  • John Theurer Cancer Center at Hackensack University Medical Center
  • NYU Clinical Cancer Center
  • Weill Cornell Medical College
  • Associates in Oncology and Hematology
  • The Don & Sybil Harrington Cancer Center
  • Baylor Sammons Cancer Center
  • UT Southwestern Medical Center at Dallas
  • The University of Texas, MD Anderson Cancer Center
  • Scott and White Memorial Hospital
  • Fred Hutchinson Cancer Research Center
  • Froedtert & Medical College of Wisconsin
  • Medizinische Universitat Wien
  • Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie
  • Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
  • AZ Sint-Jan AV
  • UZ Brussel
  • Institut Jules Bordet
  • Cliniques Universitaires Saint-Luc
  • UZ Leuven
  • University Multiprofile Hospital for Active Treatment, "Dr. Georgi Stranski"
  • University Multiprofile Hospital for Active Treatment "Sveti Georgi"
  • Military Medical Academy Multiprofile Hospital for Active Treatment
  • Specialized Hospital for Active Treatment of Hematological Diseases
  • Multiprofile Hospital for Active Treatment "Sveta Marina"
  • Tom Baker Cancer Centre
  • University of Alberta, Cross Cancer Institute
  • Vancouver General Hospital
  • Cancer Care Manitoba
  • General Hospital, Health Sciences Centre
  • Princess Margaret Hospital
  • McGill University Health Center, Royal Victoria Hospital
  • Sir Mortimer B. Davis - Jewish General Hospital
  • University Hospital Brno, Department of Internal Medicine - Hematooncology
  • University Hospital Hradec Kralove
  • University Hospital Olomouc
  • University Hospital Kralovske Vinohrady - Prague
  • General University Hospital Prague
  • Hospital Antoine Beclere
  • Clinique Victor Hugo - Centre Jean Bernard
  • Hopital Claude Huriez
  • CH de Mulhouse, Hopital Emile Muller
  • CHU Nantes Hotel Dieu
  • Hopital Saint-Antoine
  • Groupe Hospitalier Necker - Enfants Malades
  • Cancer Institut Universitaire de Toulouse-Oncopole (iUCT)
  • Hopitaux de Brabois
  • University of Dusseldorf
  • Krankenhaus Nordwest
  • University of Hamburg-Eppendorf
  • Universitat Heidelberg
  • Stiftungsklinikum Mittelrhein
  • LMU Klinikum der Universitat
  • Universitatsklinikum Munster
  • Universitatsklinikum Wurzburg
  • Alexandra Hospital
  • University General Hospital of Patras
  • St. Istvan and St. Laszlo Hospital of Budapest
  • University of Debrecen, Medical and Health Science Center
  • Petz Aladar County Teaching Hospital
  • Bekes County Pandy Kalman Hospital
  • Kaposi Mor County Teaching Hospital
  • University of Pecs
  • University of Szeged, Albert Szent-Gyorgi Clinical Center
  • Rambam Medical Center
  • Hadassah Medical Center, Ein Kerem
  • Western Gailee Hospital - Nahariya
  • Rabin Medical Center
  • The Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Azienda Ospedallera Niguarda Ca Granda
  • Azienda Ospedllero Maggiore della Carita
  • Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main
  • Ospedale S. Eugenio
  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino
  • Erasmus MC, Department of Haematology
  • University Clinical Centre, Department of Hematologii Transplantologii
  • Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp.
  • Independent Public Teaching Hospital of Medical University of Silesia in Katowice
  • Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz
  • Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach
  • Nicolaus Copernicus Municipal Specialist Hospital
  • Maria Sklodowska-Curie Institute of Oncology
  • Zamojski Non-Public Hospital
  • Fundeni Clinical Institute, "Stefan Berceanu" Center for Hematology and Bone Marrow Transplantation
  • Coltea Clinical Hospital
  • Bucharest University Emergency Hospital
  • Regional Institute of Iasi
  • State Medical Institution Komi Republican Oncological Center
  • First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia
  • Federal State Budgetary Scientific Institution: N.N. Blokhin Russian Cancer Research Center
  • Moscow State Medical Institution Municipal City Clinical Hospital n.a. S.P. Botkin
  • Federal State Budget Institution: Hematology Research Center under MoH
  • FSBI: Russian Research Institute of Hematology and Blood Transfusion under the Ferderal Agency for M&B
  • State Higher Educational Institution: St Petersburg State Medical University n.a.I.P Pavlov
  • SHEI: First St. Petersburg State Medical University N.a.I.P Pavlov under MoH, Clinic of Bone Marrow Transplant
  • Federal State Budget Institute: Federal Almalov Medical Research Centre under Ministry of Healthcare
  • Clinical Center of Serbia, Clinic of Hematology
  • Clinical Hospital Center Bezanijska Kosa
  • Military Medical Academy, Clinic of Hematology
  • Clinical Center Nis, Clinic of Hematology
  • Clinical Center of Vojvodina, Clinic of Hematology
  • Hospital Universitario Germans Trias i Pujol
  • Hospital Clinic I Provincial
  • Hospital Universitario de Salamanca
  • Hospital Donostia
  • Hospital Universitario y Politeecnico La Fe
  • Hospital Universitario Miguel Servet
  • Sahlgrenska Universitetssjukhuset
  • Karolinska Universitetsjukhuset i Huddinge
  • Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum
  • St. Bartholomew's Hospital
  • Royal Free Hampstead
  • St. Georges Hospital
  • Nottingham University Hospitals (City Campus)
  • Royal Marsden Hospital
  • The Royal Wolverhampton Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Lenalidomide and Dexamethasone (Rd)

Carfilzomib, Lenalidomide, and Dexamethasone (CRd)

Arm Description

Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22.

Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, escalating to 27 mg/m² on days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 from cycle 1 through cycle 18 and from cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 from cycle 1 through cycle 18 and from cycle 19 and higher.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).

Secondary Outcome Measures

Overall Survival
Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.
Overall Response Rate
Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).
Disease Control Rate
Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).
Duration of Response
Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
Duration of Disease Control
Duration of disease control (DDC) was calculated for participants who achieved disease control. DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.

Full Information

First Posted
March 2, 2010
Last Updated
September 8, 2022
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01080391
Brief Title
Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
Official Title
A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 14, 2010 (Actual)
Primary Completion Date
June 16, 2014 (Actual)
Study Completion Date
December 5, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.
Detailed Description
This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for adults with relapsed multiple myeloma. Eligible subjects will be randomized in a 1:1 ratio to receive either the control Rd or CRd. Randomization will be stratified by β2 microglobulin levels (< vs ≥ 2.5 mg/L), prior bortezomib (no vs yes), and prior lenalidomide (no vs yes). Participants will receive the treatment determined by randomization in 28-day cycles until disease progression or unacceptable toxicity (whichever occurs first).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Multiple Myeloma
Keywords
Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
792 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide and Dexamethasone (Rd)
Arm Type
Active Comparator
Arm Description
Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22.
Arm Title
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Arm Type
Experimental
Arm Description
Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, escalating to 27 mg/m² on days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 from cycle 1 through cycle 18 and from cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 from cycle 1 through cycle 18 and from cycle 19 and higher.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
40 mg orally or IV on days 1, 8, 15, 22
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
25 mg orally on days 1-21
Intervention Type
Drug
Intervention Name(s)
Carfilzomib
Other Intervention Name(s)
PR-171, Kyprolis®
Intervention Description
20 mg/m², 27 mg/m² intravenously
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).
Time Frame
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.
Time Frame
From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.
Title
Overall Response Rate
Description
Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).
Time Frame
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Title
Disease Control Rate
Description
Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).
Time Frame
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Title
Duration of Response
Description
Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
Time Frame
From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.
Title
Duration of Disease Control
Description
Duration of disease control (DDC) was calculated for participants who achieved disease control. DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
Time Frame
From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.
Title
Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
Description
Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.
Time Frame
Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic multiple myeloma Measurable disease, as defined by one or more of the following (assessed within 21 days prior to randomization): Serum M-protein ≥ 0.5 g/dL Urine Bence-Jones protein ≥ 200 mg/24 hours For immunoglobulin A (IgA) patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL) Prior treatment with at least one, but no more than three, regimens for multiple myeloma Documented relapse or progressive disease on or after any regimen Achieved a response to at least one prior regimen Age ≥ 18 years Life expectancy ≥ 3 months Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Adequate hepatic function, with serum alanine aminotransferase (ALT) ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dL (34 µmol/L) within 21 days prior to randomization Absolute neutrophil count ≥ 1.0 × 10^9/L within 21 days prior to randomization Hemoglobin ≥ 8 g/dL (80 g/L) within 21 days prior to randomization Platelet count ≥ 50 × 10^9/L (≥ 30 × 10^9/L if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization Creatinine clearance (CrCl) ≥ 50 mL/minute within 21 days prior to randomization Written informed consent in accordance with federal, local, and institutional guidelines Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception Male subjects must agree to practice contraception Exclusion Criteria: If previously treated with bortezomib (alone or in combination), progression during treatment If previously treated with a lenalidomide and dexamethasone (len/dex) combination: Progression during the first 3 months of initiating treatment Any progression during treatment if the len/dex combination was the subject's most recent line of therapy Discontinuation of previous lenalidomide or dexamethasone due to intolerance; subjects intolerant to bortezomib are not excluded Prior carfilzomib treatment POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) Waldenström's macroglobulinemia or IgM myeloma Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential) Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization Radiotherapy to multiple sites or immunotherapy/antibody therapy within 28 days prior to randomization; localized radiotherapy to a single site within 7 days prior to randomization Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization Pregnant or lactating females Major surgery within 21 days prior to randomization Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomization Known human immunodeficiency virus infection Active hepatitis B or C infection Myocardial infarction within 4 months prior to randomization, New York Hear Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization Other malignancy, including myelodysplastic syndromes (MDS), within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib) Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment Ongoing graft-vs-host disease Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Providence St. Joseph Medical Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
St. Jude Hospital Yorba Linda dba; St. Joseph Heritage Healthcare
City
Santa Rosa
State/Province
California
ZIP/Postal Code
94503
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Cancer and Blood Disease Center
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University Health Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
The University of Michigan - Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
NYU Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Associates in Oncology and Hematology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
The Don & Sybil Harrington Cancer Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8565
Country
United States
Facility Name
The University of Texas, MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott and White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Froedtert & Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Medizinische Universitat Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie
City
Wien
ZIP/Postal Code
1171
Country
Austria
Facility Name
Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
AZ Sint-Jan AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UZ Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University Multiprofile Hospital for Active Treatment, "Dr. Georgi Stranski"
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment "Sveti Georgi"
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Military Medical Academy Multiprofile Hospital for Active Treatment
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Hematological Diseases
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment "Sveta Marina"
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
University of Alberta, Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
General Hospital, Health Sciences Centre
City
St John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University Health Center, Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Sir Mortimer B. Davis - Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
University Hospital Brno, Department of Internal Medicine - Hematooncology
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
University Hospital Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
University Hospital Kralovske Vinohrady - Prague
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
General University Hospital Prague
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Hospital Antoine Beclere
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Clinique Victor Hugo - Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CH de Mulhouse, Hopital Emile Muller
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Facility Name
CHU Nantes Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Groupe Hospitalier Necker - Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Cancer Institut Universitaire de Toulouse-Oncopole (iUCT)
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Name
Hopitaux de Brabois
City
Vandoeuvre-Les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
University of Dusseldorf
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Krankenhaus Nordwest
City
Frankfurt am Main
ZIP/Postal Code
60488
Country
Germany
Facility Name
University of Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitat Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Stiftungsklinikum Mittelrhein
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
LMU Klinikum der Universitat
City
Munchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitatsklinikum Munster
City
Munster
ZIP/Postal Code
48129
Country
Germany
Facility Name
Universitatsklinikum Wurzburg
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Alexandra Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
University General Hospital of Patras
City
Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
St. Istvan and St. Laszlo Hospital of Budapest
City
Budapest
ZIP/Postal Code
H-1097
Country
Hungary
Facility Name
University of Debrecen, Medical and Health Science Center
City
Debrecen
ZIP/Postal Code
H-4032
Country
Hungary
Facility Name
Petz Aladar County Teaching Hospital
City
Gyor
ZIP/Postal Code
H-9032
Country
Hungary
Facility Name
Bekes County Pandy Kalman Hospital
City
Gyula
ZIP/Postal Code
H-5700
Country
Hungary
Facility Name
Kaposi Mor County Teaching Hospital
City
Kaposvar
ZIP/Postal Code
H-7400
Country
Hungary
Facility Name
University of Pecs
City
Pecs
ZIP/Postal Code
H-7624
Country
Hungary
Facility Name
University of Szeged, Albert Szent-Gyorgi Clinical Center
City
Szeged
ZIP/Postal Code
H-6720
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Center, Ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Western Gailee Hospital - Nahariya
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Azienda Ospedallera Niguarda Ca Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Azienda Ospedllero Maggiore della Carita
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main
City
Pisa
ZIP/Postal Code
56216
Country
Italy
Facility Name
Ospedale S. Eugenio
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Erasmus MC, Department of Haematology
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
University Clinical Centre, Department of Hematologii Transplantologii
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp.
City
Gorzow Wielkopolski
ZIP/Postal Code
66-400
Country
Poland
Facility Name
Independent Public Teaching Hospital of Medical University of Silesia in Katowice
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Facility Name
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach
City
Suwalki
ZIP/Postal Code
16-400
Country
Poland
Facility Name
Nicolaus Copernicus Municipal Specialist Hospital
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Maria Sklodowska-Curie Institute of Oncology
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Zamojski Non-Public Hospital
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Fundeni Clinical Institute, "Stefan Berceanu" Center for Hematology and Bone Marrow Transplantation
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Coltea Clinical Hospital
City
Bucharest
ZIP/Postal Code
030-171
Country
Romania
Facility Name
Bucharest University Emergency Hospital
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Regional Institute of Iasi
City
Iasi
ZIP/Postal Code
700483
Country
Romania
Facility Name
State Medical Institution Komi Republican Oncological Center
City
Syktyvkar
State/Province
Komi Republic
ZIP/Postal Code
167904
Country
Russian Federation
Facility Name
First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia
City
Izhevsk
ZIP/Postal Code
426039
Country
Russian Federation
Facility Name
Federal State Budgetary Scientific Institution: N.N. Blokhin Russian Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Moscow State Medical Institution Municipal City Clinical Hospital n.a. S.P. Botkin
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
Facility Name
Federal State Budget Institution: Hematology Research Center under MoH
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
FSBI: Russian Research Institute of Hematology and Blood Transfusion under the Ferderal Agency for M&B
City
St. Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
State Higher Educational Institution: St Petersburg State Medical University n.a.I.P Pavlov
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
SHEI: First St. Petersburg State Medical University N.a.I.P Pavlov under MoH, Clinic of Bone Marrow Transplant
City
St. Petersburg
ZIP/Postal Code
197101
Country
Russian Federation
Facility Name
Federal State Budget Institute: Federal Almalov Medical Research Centre under Ministry of Healthcare
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Clinical Center of Serbia, Clinic of Hematology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Bezanijska Kosa
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Military Medical Academy, Clinic of Hematology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Nis, Clinic of Hematology
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
Clinical Center of Vojvodina, Clinic of Hematology
City
Novi Sad
ZIP/Postal Code
21 000
Country
Serbia
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Donostia
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Hospital Universitario y Politeecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Sahlgrenska Universitetssjukhuset
City
Goteborg
ZIP/Postal Code
SE-41345
Country
Sweden
Facility Name
Karolinska Universitetsjukhuset i Huddinge
City
Stockholm
ZIP/Postal Code
SE-14186
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum
City
Stockholm
ZIP/Postal Code
SE-17176
Country
Sweden
Facility Name
St. Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Free Hampstead
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
St. Georges Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Nottingham University Hospitals (City Campus)
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Royal Wolverhampton Hospital NHS Trust
City
Wolverhampton
ZIP/Postal Code
WV10 OQP
Country
United Kingdom

12. IPD Sharing Statement

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Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

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