AzTrials
AzTrials

Relapsed Multiple MyelomaPhase 3NCT01080391

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

A Phase 3 study testing Dexamethasone, Lenalidomide and Carfilzomib in people with Relapsed Multiple Myeloma, run by Amgen at 127 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed Multiple Myeloma
What is being tested?
Dexamethasone, Lenalidomide and Carfilzomib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
792 participants
Where
127 sitesin 20 countries
Study dates
14 Jul 2010to 5 Dec 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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

Trial locations and contacts

127 sites in 20 countries.

127 sites in 20 countries

United States22 sites

  • The Don & Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • The University of Michigan - Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Providence St. Joseph Medical Center

    Burbank, California, 91505

  • Associates in Oncology and Hematology

    Chattanooga, Tennessee, 37404

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Baylor Sammons Cancer Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-8565

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Cancer and Blood Disease Center

    Lecanto, Florida, 34461

  • Froedtert & Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • NYU Clinical Cancer Center

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • St. Jude Hospital Yorba Linda dba; St. Joseph Heritage Healthcare

    Santa Rosa, California, 94503

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Stanford University

    Stanford, California, 94305

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

Other trials in United States

France9 sites

  • Hospital Antoine Beclere

    Clamart, 92140

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, 72000

  • Hopital Claude Huriez

    Lille, 59037

  • CH de Mulhouse, Hopital Emile Muller

    Mulhouse, 68070

  • CHU Nantes Hotel Dieu

    Nantes, 44093

  • Hopital Saint-Antoine

    Paris, 75012

  • Groupe Hospitalier Necker - Enfants Malades

    Paris, 75015

  • Cancer Institut Universitaire de Toulouse-Oncopole (iUCT)

    Toulouse, 31100

  • Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Russia9 sites

  • First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia

    Izhevsk, 426039

  • Federal State Budgetary Scientific Institution: N.N. Blokhin Russian Cancer Research Center

    Moscow, 115478

  • Moscow State Medical Institution Municipal City Clinical Hospital n.a. S.P. Botkin

    Moscow, 125101

  • Federal State Budget Institution: Hematology Research Center under MoH

    Moscow, 125167

  • FSBI: Russian Research Institute of Hematology and Blood Transfusion under the Ferderal Agency for M&B

    Saint Petersburg, 191024

  • State Higher Educational Institution: St Petersburg State Medical University n.a.I.P Pavlov

    Saint Petersburg, 197022

  • SHEI: First St. Petersburg State Medical University N.a.I.P Pavlov under MoH, Clinic of Bone Marrow Transplant

    Saint Petersburg, 197101

  • Federal State Budget Institute: Federal Almalov Medical Research Centre under Ministry of Healthcare

    Saint Petersburg, 197341

  • State Medical Institution Komi Republican Oncological Center

    Syktyvkar, Komi, 167904

Other trials in Russia

Canada8 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • University of Alberta, Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • McGill University Health Center, Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Sir Mortimer B. Davis - Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • General Hospital, Health Sciences Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Germany8 sites

  • University of Dusseldorf

    Düsseldorf, 40225

  • Krankenhaus Nordwest

    Frankfurt am Main, 60488

  • University of Hamburg-Eppendorf

    Hamburg, 20246

  • Universitat Heidelberg

    Heidelberg, 69120

  • Stiftungsklinikum Mittelrhein

    Koblenz, 56068

  • LMU Klinikum der Universitat

    München, 81377

  • Universitatsklinikum Munster

    Münster, 48129

  • Universitatsklinikum Wurzburg

    Würzburg, 97080

Other trials in Germany

Poland8 sites

  • University Clinical Centre, Department of Hematologii Transplantologii

    Gdansk, 80-952

  • Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp.

    Gorzów Wielkopolski, 66-400

  • Independent Public Teaching Hospital of Medical University of Silesia in Katowice

    Katowice, 40-027

  • Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz

    Lodz, 93-510

  • Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach

    Suwałki, 16-400

  • Nicolaus Copernicus Municipal Specialist Hospital

    Torun, 87-100

  • Maria Sklodowska-Curie Institute of Oncology

    Warsaw, 02-781

  • Zamojski Non-Public Hospital

    Zamość, 22-400

Other trials in Poland

Hungary7 sites

  • St. Istvan and St. Laszlo Hospital of Budapest

    Budapest, H-1097

  • University of Debrecen, Medical and Health Science Center

    Debrecen, H-4032

  • Petz Aladar County Teaching Hospital

    Győr, H-9032

  • Bekes County Pandy Kalman Hospital

    Gyula, H-5700

  • Kaposi Mor County Teaching Hospital

    Kaposvár, H-7400

  • University of Pecs

    Pécs, H-7624

  • University of Szeged, Albert Szent-Gyorgi Clinical Center

    Szeged, H-6720

Other trials in Hungary

Belgium6 sites

  • Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

    Antwerp, 2060

  • AZ Sint-Jan AV

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Israel6 sites

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah Medical Center, Ein Kerem

    Jerusalem, 91120

  • Western Gailee Hospital - Nahariya

    Nahariya, 22100

  • Rabin Medical Center

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 76100

Other trials in Israel

Spain6 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, 08916

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Hospital Donostia

    Donostia / San Sebastian, 20014

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario y Politeecnico La Fe

    Valencia, 46026

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

United Kingdom6 sites

  • St. Bartholomew's Hospital

    London, EC1A 7BE

  • Royal Free Hampstead

    London, NW3 2QG

  • St. Georges Hospital

    London, SW17 0QT

  • Nottingham University Hospitals (City Campus)

    Nottingham, NG5 1PB

  • Royal Marsden Hospital

    Sutton, SM2 5PT

  • The Royal Wolverhampton Hospital NHS Trust

    Wolverhampton, WV10 OQP

Other trials in United Kingdom

Bulgaria5 sites

  • University Multiprofile Hospital for Active Treatment, "Dr. Georgi Stranski"

    Pleven, 5800

  • University Multiprofile Hospital for Active Treatment "Sveti Georgi"

    Plovdiv, 4002

  • Military Medical Academy Multiprofile Hospital for Active Treatment

    Sofia, 1606

  • Specialized Hospital for Active Treatment of Hematological Diseases

    Sofia, 1756

  • Multiprofile Hospital for Active Treatment "Sveta Marina"

    Varna, 9010

Other trials in Bulgaria

Czechia5 sites

  • University Hospital Brno, Department of Internal Medicine - Hematooncology

    Brno, 625 00

  • University Hospital Hradec Kralove

    Hradec Králové, 500 05

  • University Hospital Olomouc

    Olomouc, 775 20

  • University Hospital Kralovske Vinohrady - Prague

    Prague, 100 34

  • General University Hospital Prague

    Prague, 128 08

Other trials in Czechia

Italy5 sites

  • Azienda Ospedallera Niguarda Ca Granda

    Milan, 20162

  • Azienda Ospedllero Maggiore della Carita

    Novara, 28100

  • Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main

    Pisa, 56216

  • Ospedale S. Eugenio

    Roma, 00144

  • Azienda Ospedaliera Citta della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Serbia5 sites

  • Clinical Center of Serbia, Clinic of Hematology

    Belgrade, 11000

  • Clinical Hospital Center Bezanijska Kosa

    Belgrade, 11000

  • Military Medical Academy, Clinic of Hematology

    Belgrade, 11000

  • Clinical Center Nis, Clinic of Hematology

    Niš, 18 000

  • Clinical Center of Vojvodina, Clinic of Hematology

    Novi Sad, 21 000

Other trials in Serbia

Romania4 sites

  • Fundeni Clinical Institute, "Stefan Berceanu" Center for Hematology and Bone Marrow Transplantation

    Bucharest, 022328

  • Coltea Clinical Hospital

    Bucharest, 030-171

  • Bucharest University Emergency Hospital

    Bucharest, 050098

  • Regional Institute of Iasi

    Iași, 700483

Other trials in Romania

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, SE-41345

  • Karolinska Universitetsjukhuset i Huddinge

    Stockholm, SE-14186

  • Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum

    Stockholm, SE-17176

Other trials in Sweden

Austria2 sites

  • Medizinische Universitat Wien

    Vienna, 1090

  • Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie

    Vienna, 1171

Other trials in Austria

Greece2 sites

  • Alexandra Hospital

    Athens, 11528

  • University General Hospital of Patras

    Pátrai, 26500

Other trials in Greece

Netherlands1 site

  • Erasmus MC, Department of Haematology

    Rotterdam, 3015 CE

Other trials in Netherlands

About this study

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

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.

Read the 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).

Keywords
Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    40 mg orally or IV on days 1, 8, 15, 22

  • LenalidomideDrug

    Also called Revlimid

    25 mg orally on days 1-21

  • CarfilzomibDrug

    Also called PR-171, Kyprolis®

    20 mg/m², 27 mg/m² intravenously

Study groups in NCT01080391
Study groupRoleWhat they receive
Lenalidomide and Dexamethasone (Rd)Active comparatorTreatment 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.
Receives: Drug: Dexamethasone; Drug: Lenalidomide
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)ExperimentalTreatment 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.
Receives: Drug: Dexamethasone; Drug: Lenalidomide; Drug: Carfilzomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.

Secondary outcomes (6)

  1. 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.

    Measured: 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.

  2. 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).

    Measured: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.

  3. 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).

    Measured: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.

  4. 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.

    Measured: From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.

  5. 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.

    Measured: From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.

  6. 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.

    Measured: Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2010 (estimated)
  2. Study start14 Jul 2010
  3. Primary completion16 Jun 2014
  4. Study completion5 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
792 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01080391
Sponsor's protocol ID
PX-171-009
Status last verified
Sep 2022
First submitted
2 Mar 2010
Last updated
21 Sep 2022
Data monitoring committee
Yes

Publications

  • Dimopoulos M, Wang M, Maisnar V, Minarik J, Bensinger W, Mateos MV, Obreja M, Blaedel J, Moreau P. Response and progression-free survival according to planned treatment duration in patients with relapsed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in the phase III ASPIRE study. J Hematol Oncol. 2018 Apr 4;11(1):49. doi: 10.1186/s13045-018-0583-7.

    PubMed 29615082

  • Avet-Loiseau H, Fonseca R, Siegel D, Dimopoulos MA, Spicka I, Masszi T, Hajek R, Rosinol L, Goranova-Marinova V, Mihaylov G, Maisnar V, Mateos MV, Wang M, Niesvizky R, Oriol A, Jakubowiak A, Minarik J, Palumbo A, Bensinger W, Kukreti V, Ben-Yehuda D, Stewart AK, Obreja M, Moreau P. Carfilzomib significantly improves the progression-free survival of high-risk patients in multiple myeloma. Blood. 2016 Sep 1;128(9):1174-80. doi: 10.1182/blood-2016-03-707596. Epub 2016 Jul 20.

    PubMed 27439911

  • Dimopoulos MA, Stewart AK, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Ro S, Aggarwal S, Moreau P, Palumbo A. Carfilzomib-lenalidomide-dexamethasone vs lenalidomide-dexamethasone in relapsed multiple myeloma by previous treatment. Blood Cancer J. 2017 Apr 21;7(4):e554. doi: 10.1038/bcj.2017.31.

    PubMed 28430175

  • Dimopoulos MA, Stewart AK, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Palumbo A, Obreja M, Aggarwal S, Moreau P. Carfilzomib, lenalidomide, and dexamethasone in patients with relapsed multiple myeloma categorised by age: secondary analysis from the phase 3 ASPIRE study. Br J Haematol. 2017 May;177(3):404-413. doi: 10.1111/bjh.14549. Epub 2017 Feb 17.

    PubMed 28211560

  • Jakubowiak AJ, Campioni M, Benedict A, Houisse I, Tichy E, Giannopoulou A, Aggarwal SK, Barber BL, Panjabi S. Cost-effectiveness of adding carfilzomib to lenalidomide and dexamethasone in relapsed multiple myeloma from a US perspective. J Med Econ. 2016 Nov;19(11):1061-1074. doi: 10.1080/13696998.2016.1194278. Epub 2016 Jun 16.

    PubMed 27224006

  • Stewart AK, Dimopoulos MA, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel DS, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Buchanan J, Cocks K, Yang X, Xing B, Zojwalla N, Tonda M, Moreau P, Palumbo A. Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma. J Clin Oncol. 2016 Nov 10;34(32):3921-3930. doi: 10.1200/JCO.2016.66.9648.

    PubMed 27601539

  • Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545.

    PubMed 29991494

  • Facon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965.

    PubMed 33166401

  • Hari P, Mateos MV, Abonour R, Knop S, Bensinger W, Ludwig H, Song K, Hajek R, Moreau P, Siegel DS, Feng S, Obreja M, Aggarwal SK, Iskander K, Goldschmidt H. Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes. Leukemia. 2017 Dec;31(12):2630-2641. doi: 10.1038/leu.2017.122. Epub 2017 Apr 25.

    PubMed 28439109

  • Leleu X, Martin TG, Einsele H, Lyons RM, Durie BGM, Iskander KS, Ailawadhi S. Role of Proteasome Inhibitors in Relapsed and/or Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019 Jan;19(1):9-22. doi: 10.1016/j.clml.2018.08.016. Epub 2018 Sep 5.

    PubMed 30287200

  • Mateos MV, Goldschmidt H, San-Miguel J, Mikhael J, DeCosta L, Zhou L, Obreja M, Blaedel J, Szabo Z, Leleu X. Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. Hematol Oncol. 2018 Apr;36(2):463-470. doi: 10.1002/hon.2499. Epub 2018 Feb 15.

    PubMed 29446103

  • Siegel DS, Dimopoulos MA, Ludwig H, Facon T, Goldschmidt H, Jakubowiak A, San-Miguel J, Obreja M, Blaedel J, Stewart AK. Improvement in Overall Survival With Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma. J Clin Oncol. 2018 Mar 10;36(8):728-734. doi: 10.1200/JCO.2017.76.5032. Epub 2018 Jan 17.

    PubMed 29341834

  • Weisel K, Mateos MV, Gay F, Delforge M, Cook G, Szabo Z, Desgraz R, DeCosta L, Moreau P. Efficacy and safety profile of deep responders to carfilzomib-based therapy: a subgroup analysis from ASPIRE and ENDEAVOR. Leukemia. 2021 Jun;35(6):1732-1744. doi: 10.1038/s41375-020-01049-5. Epub 2020 Oct 16.

    PubMed 33067574

  • Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel DS, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Wang M, Maisnar V, Minarik J, Bensinger WI, Mateos MV, Ben-Yehuda D, Kukreti V, Zojwalla N, Tonda ME, Yang X, Xing B, Moreau P, Palumbo A; ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015 Jan 8;372(2):142-52. doi: 10.1056/NEJMoa1411321. Epub 2014 Dec 6.

    PubMed 25482145

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone, Lenalidomide and Carfilzomib in people with Relapsed Multiple Myeloma, run by Amgen at 127 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, France, Russia, Canada, Germany and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01080391, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in