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

NCT01080391 | Completed Phase 3 Results DMC

• 1 other identifier: PX-171-009
• Study Type: interventional
• Target: 792
• Locations: 19 countries
• Sites: 122

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.

Conditions

Relapsed Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (6)

• Overall Survival

  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.

• Overall Response Rate

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

• Disease Control Rate

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

• Duration of Response

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

• Duration of Disease Control

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

Study Arms (2)

Lenalidomide and Dexamethasone (Rd)

ACTIVE COMPARATOR

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.

Drug: Dexamethasone; Drug: Lenalidomide

Carfilzomib, Lenalidomide, and Dexamethasone (CRd)

EXPERIMENTAL

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.

Drug: Dexamethasone; Drug: Lenalidomide; Drug: Carfilzomib

Interventions

Dexamethasone DRUG

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

Carfilzomib, Lenalidomide, and Dexamethasone (CRd); Lenalidomide and Dexamethasone (Rd)

Lenalidomide DRUG

25 mg orally on days 1-21

Also known as: Revlimid

Carfilzomib, Lenalidomide, and Dexamethasone (CRd); Lenalidomide and Dexamethasone (Rd)

Carfilzomib DRUG

20 mg/m², 27 mg/m² intravenously

Also known as: PR-171, Kyprolis®

Carfilzomib, Lenalidomide, and Dexamethasone (CRd)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (127)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Providence St. Joseph Medical Center

Burbank, California, 91505, United States

Location

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

Santa Rosa, California, 94503, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Cancer and Blood Disease Center

Lecanto, Florida, 34461, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

Location

The University of Michigan - Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Associates in Oncology and Hematology

Chattanooga, Tennessee, 37404, United States

Location

The Don & Sybil Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Baylor Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center at Dallas

Dallas, Texas, 75390-8565, United States

Location

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Medizinische Universitat Wien

Vienna, 1090, Austria

Location

Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie

Vienna, 1171, Austria

Location

Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

Antwerp, 2060, Belgium

Location

AZ Sint-Jan AV

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

UZ Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

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

Pleven, 5800, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Sveti Georgi"

Plovdiv, 4002, Bulgaria

Location

Military Medical Academy Multiprofile Hospital for Active Treatment

Sofia, 1606, Bulgaria

Location

Specialized Hospital for Active Treatment of Hematological Diseases

Sofia, 1756, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Sveta Marina"

Varna, 9010, Bulgaria

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

University of Alberta, Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

General Hospital, Health Sciences Centre

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

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Health Center, Royal Victoria Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

University Hospital Brno, Department of Internal Medicine - Hematooncology

Brno, 625 00, Czechia

Location

University Hospital Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

University Hospital Olomouc

Olomouc, 775 20, Czechia

Location

University Hospital Kralovske Vinohrady - Prague

Prague, 100 34, Czechia

Location

General University Hospital Prague

Prague, 128 08, Czechia

Location

Hospital Antoine Beclere

Clamart, 92140, France

Location

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, 72000, France

Location

Hopital Claude Huriez

Lille, 59037, France

Location

CH de Mulhouse, Hopital Emile Muller

Mulhouse, 68070, France

Location

CHU Nantes Hotel Dieu

Nantes, 44093, France

Location

Hopital Saint-Antoine

Paris, 75012, France

Location

Groupe Hospitalier Necker - Enfants Malades

Paris, 75015, France

Location

Cancer Institut Universitaire de Toulouse-Oncopole (iUCT)

Toulouse, 31100, France

Location

Hopitaux de Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

University of Dusseldorf

Düsseldorf, 40225, Germany

Location

Krankenhaus Nordwest

Frankfurt am Main, 60488, Germany

Location

University of Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Universitat Heidelberg

Heidelberg, 69120, Germany

Location

Stiftungsklinikum Mittelrhein

Koblenz, 56068, Germany

Location

LMU Klinikum der Universitat

München, 81377, Germany

Location

Universitatsklinikum Munster

Münster, 48129, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

Alexandra Hospital

Athens, 11528, Greece

Location

University General Hospital of Patras

Pátrai, 26500, Greece

Location

St. Istvan and St. Laszlo Hospital of Budapest

Budapest, H-1097, Hungary

Location

University of Debrecen, Medical and Health Science Center

Debrecen, H-4032, Hungary

Location

Petz Aladar County Teaching Hospital

Győr, H-9032, Hungary

Location

Bekes County Pandy Kalman Hospital

Gyula, H-5700, Hungary

Location

Kaposi Mor County Teaching Hospital

Kaposvár, H-7400, Hungary

Location

University of Pecs

Pécs, H-7624, Hungary

Location

University of Szeged, Albert Szent-Gyorgi Clinical Center

Szeged, H-6720, Hungary

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Hadassah Medical Center, Ein Kerem

Jerusalem, 91120, Israel

Location

Western Gailee Hospital - Nahariya

Nahariya, 22100, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

The Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Azienda Ospedallera Niguarda Ca Granda

Milan, 20162, Italy

Location

Azienda Ospedllero Maggiore della Carita

Novara, 28100, Italy

Location

Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main

Pisa, 56216, Italy

Location

Ospedale S. Eugenio

Roma, 00144, Italy

Location

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Erasmus MC, Department of Haematology

Rotterdam, 3015 CE, Netherlands

Location

University Clinical Centre, Department of Hematologii Transplantologii

Gdansk, 80-952, Poland

Location

Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp.

Gorzów Wielkopolski, 66-400, Poland

Location

Independent Public Teaching Hospital of Medical University of Silesia in Katowice

Katowice, 40-027, Poland

Location

Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz

Lodz, 93-510, Poland

Location

Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach

Suwałki, 16-400, Poland

Location

Nicolaus Copernicus Municipal Specialist Hospital

Torun, 87-100, Poland

Location

Maria Sklodowska-Curie Institute of Oncology

Warsaw, 02-781, Poland

Location

Zamojski Non-Public Hospital

Zamość, 22-400, Poland

Location

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

Bucharest, 022328, Romania

Location

Coltea Clinical Hospital

Bucharest, 030-171, Romania

Location

Bucharest University Emergency Hospital

Bucharest, 050098, Romania

Location

Regional Institute of Iasi

Iași, 700483, Romania

Location

State Medical Institution Komi Republican Oncological Center

Syktyvkar, Komi, 167904, Russia

Location

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

Izhevsk, 426039, Russia

Location

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

Moscow, 115478, Russia

Location

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

Moscow, 125101, Russia

Location

Federal State Budget Institution: Hematology Research Center under MoH

Moscow, 125167, Russia

Location

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

Saint Petersburg, 191024, Russia

Location

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

Saint Petersburg, 197022, Russia

Location

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

Saint Petersburg, 197101, Russia

Location

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

Saint Petersburg, 197341, Russia

Location

Clinical Center of Serbia, Clinic of Hematology

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Bezanijska Kosa

Belgrade, 11000, Serbia

Location

Military Medical Academy, Clinic of Hematology

Belgrade, 11000, Serbia

Location

Clinical Center Nis, Clinic of Hematology

Niš, 18 000, Serbia

Location

Clinical Center of Vojvodina, Clinic of Hematology

Novi Sad, 21 000, Serbia

Location

Hospital Universitario Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Clinic I Provincial

Barcelona, 08036, Spain

Location

Hospital Donostia

Donostia / San Sebastian, 20014, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario y Politeecnico La Fe

Valencia, 46026, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, SE-41345, Sweden

Location

Karolinska Universitetsjukhuset i Huddinge

Stockholm, SE-14186, Sweden

Location

Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum

Stockholm, SE-17176, Sweden

Location

St. Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Royal Free Hampstead

London, NW3 2QG, United Kingdom

Location

St. Georges Hospital

London, SW17 0QT, United Kingdom

Location

Nottingham University Hospitals (City Campus)

Nottingham, NG5 1PB, United Kingdom

Location

Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

The Royal Wolverhampton Hospital NHS Trust

Wolverhampton, WV10 OQP, United Kingdom

Location

Related Publications (14)

• 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.

  PMID: 29615082 BACKGROUND

• 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.

  PMID: 27439911 BACKGROUND

• 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.

  PMID: 28430175 BACKGROUND

• 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.

  PMID: 28211560 BACKGROUND

• 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.

  PMID: 27224006 BACKGROUND

• 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.

  PMID: 27601539 BACKGROUND

• 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.

  PMID: 29991494 BACKGROUND

• 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.

  PMID: 33166401 BACKGROUND

• 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.

  PMID: 28439109 BACKGROUND

• 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.

  PMID: 30287200 BACKGROUND

• 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.

  PMID: 29446103 BACKGROUND

• 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.

  PMID: 29341834 BACKGROUND

• 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.

  PMID: 33067574 BACKGROUND

• 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.

  PMID: 25482145 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Dexamethasone; Lenalidomide; carfilzomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 4, 2010
• Study Start: July 14, 2010
• Primary Completion: June 16, 2014
• Study Completion: December 5, 2017
• Last Updated: September 21, 2022
• Results First Posted: July 8, 2015

Record last verified: 2022-09

Locations

BU (5); CA (8); ES (6); DE (8); PL (8); BE (6); IL (6); IT (5); GB (6); AU (2); RO (4); CZ (5); SE (3); RU (9); GR (2); HU (7); FR (9); US (22); NL (1)