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

NCT ID: NCT01080391

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 792 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-14
• Study Completion Date: 2017-12-05

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).

Conditions

Relapsed Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenalidomide and Dexamethasone (Rd)

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

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

Lenalidomide

Intervention Type: DRUG

25 mg orally on days 1-21

Carfilzomib, Lenalidomide, and Dexamethasone (CRd)

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.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

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

Lenalidomide

Intervention Type: DRUG

25 mg orally on days 1-21

Carfilzomib

Intervention Type: DRUG

20 mg/m², 27 mg/m² intravenously

Interventions

Dexamethasone

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

Intervention Type: DRUG

Lenalidomide

25 mg orally on days 1-21

Intervention Type: DRUG

Carfilzomib

20 mg/m², 27 mg/m² intravenously

Intervention Type: DRUG

Other Intervention Names

Revlimid; PR-171; Kyprolis®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Mayo Clinic

Scottsdale, Arizona, United States

Providence St. Joseph Medical Center

Burbank, California, United States

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

Santa Rosa, California, United States

Stanford University

Stanford, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Cancer and Blood Disease Center

Lecanto, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

The University of Michigan - Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

NYU Clinical Cancer Center

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

Associates in Oncology and Hematology

Chattanooga, Tennessee, United States

The Don & Sybil Harrington Cancer Center

Amarillo, Texas, United States

Baylor Sammons Cancer Center

Dallas, Texas, United States

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

The University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

Scott and White Memorial Hospital

Temple, Texas, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Medizinische Universitat Wien

Vienna, , Austria

Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie

Vienna, , Austria

Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

Antwerp, , Belgium

AZ Sint-Jan AV

Bruges, , Belgium

Institut Jules Bordet

Brussels, , Belgium

UZ Brussel

Brussels, , Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

UZ Leuven

Leuven, , Belgium

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

Pleven, , Bulgaria

University Multiprofile Hospital for Active Treatment "Sveti Georgi"

Plovdiv, , Bulgaria

Military Medical Academy Multiprofile Hospital for Active Treatment

Sofia, , Bulgaria

Specialized Hospital for Active Treatment of Hematological Diseases

Sofia, , Bulgaria

Multiprofile Hospital for Active Treatment "Sveta Marina"

Varna, , Bulgaria

Tom Baker Cancer Centre

Calgary, Alberta, Canada

University of Alberta, Cross Cancer Institute

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

General Hospital, Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

McGill University Health Center, Royal Victoria Hospital

Montreal, Quebec, Canada

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, Canada

University Hospital Brno, Department of Internal Medicine - Hematooncology

Brno, , Czechia

University Hospital Hradec Kralove

Hradec Králové, , Czechia

University Hospital Olomouc

Olomouc, , Czechia

University Hospital Kralovske Vinohrady - Prague

Prague, , Czechia

General University Hospital Prague

Prague, , Czechia

Hospital Antoine Beclere

Clamart, , France

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, , France

Hopital Claude Huriez

Lille, , France

CH de Mulhouse, Hopital Emile Muller

Mulhouse, , France

CHU Nantes Hotel Dieu

Nantes, , France

Hopital Saint-Antoine

Paris, , France

Groupe Hospitalier Necker - Enfants Malades

Paris, , France

Cancer Institut Universitaire de Toulouse-Oncopole (iUCT)

Toulouse, , France

Hopitaux de Brabois

Vandœuvre-lès-Nancy, , France

University of Dusseldorf

Düsseldorf, , Germany

Krankenhaus Nordwest

Frankfurt am Main, , Germany

University of Hamburg-Eppendorf

Hamburg, , Germany

Universitat Heidelberg

Heidelberg, , Germany

Stiftungsklinikum Mittelrhein

Koblenz, , Germany

LMU Klinikum der Universitat

München, , Germany

Universitatsklinikum Munster

Münster, , Germany

Universitatsklinikum Wurzburg

Würzburg, , Germany

Alexandra Hospital

Athens, , Greece

University General Hospital of Patras

Pátrai, , Greece

St. Istvan and St. Laszlo Hospital of Budapest

Budapest, , Hungary

University of Debrecen, Medical and Health Science Center

Debrecen, , Hungary

Petz Aladar County Teaching Hospital

Győr, , Hungary

Bekes County Pandy Kalman Hospital

Gyula, , Hungary

Kaposi Mor County Teaching Hospital

Kaposvár, , Hungary

University of Pecs

Pécs, , Hungary

University of Szeged, Albert Szent-Gyorgi Clinical Center

Szeged, , Hungary

Rambam Medical Center

Haifa, , Israel

Hadassah Medical Center, Ein Kerem

Jerusalem, , Israel

Western Gailee Hospital - Nahariya

Nahariya, , Israel

Rabin Medical Center

Petah Tikva, , Israel

The Chaim Sheba Medical Center

Ramat Gan, , Israel

Kaplan Medical Center

Rehovot, , Israel

Azienda Ospedallera Niguarda Ca Granda

Milan, , Italy

Azienda Ospedllero Maggiore della Carita

Novara, , Italy

Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main

Pisa, , Italy

Ospedale S. Eugenio

Roma, , Italy

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Torino, , Italy

Erasmus MC, Department of Haematology

Rotterdam, , Netherlands

University Clinical Centre, Department of Hematologii Transplantologii

Gdansk, , Poland

Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp.

Gorzów Wielkopolski, , Poland

Independent Public Teaching Hospital of Medical University of Silesia in Katowice

Katowice, , Poland

Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz

Lodz, , Poland

Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach

Suwałki, , Poland

Nicolaus Copernicus Municipal Specialist Hospital

Torun, , Poland

Maria Sklodowska-Curie Institute of Oncology

Warsaw, , Poland

Zamojski Non-Public Hospital

Zamość, , Poland

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

Bucharest, , Romania

Coltea Clinical Hospital

Bucharest, , Romania

Bucharest University Emergency Hospital

Bucharest, , Romania

Regional Institute of Iasi

Iași, , Romania

State Medical Institution Komi Republican Oncological Center

Syktyvkar, Komi, Russia

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

Izhevsk, , Russia

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

Moscow, , Russia

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

Moscow, , Russia

Federal State Budget Institution: Hematology Research Center under MoH

Moscow, , Russia

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

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

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

Saint Petersburg, , Russia

Clinical Center of Serbia, Clinic of Hematology

Belgrade, , Serbia

Clinical Hospital Center Bezanijska Kosa

Belgrade, , Serbia

Military Medical Academy, Clinic of Hematology

Belgrade, , Serbia

Clinical Center Nis, Clinic of Hematology

Niš, , Serbia

Clinical Center of Vojvodina, Clinic of Hematology

Novi Sad, , Serbia

Hospital Universitario Germans Trias i Pujol

Badalona, , Spain

Hospital Clinic I Provincial

Barcelona, , Spain

Hospital Donostia

Donostia / San Sebastian, , Spain

Hospital Universitario de Salamanca

Salamanca, , Spain

Hospital Universitario y Politeecnico La Fe

Valencia, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Karolinska Universitetsjukhuset i Huddinge

Stockholm, , Sweden

Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum

Stockholm, , Sweden

St. Bartholomew's Hospital

London, , United Kingdom

Royal Free Hampstead

London, , United Kingdom

St. Georges Hospital

London, , United Kingdom

Nottingham University Hospitals (City Campus)

Nottingham, , United Kingdom

Royal Marsden Hospital

Sutton, , United Kingdom

The Royal Wolverhampton Hospital NHS Trust

Wolverhampton, , United Kingdom

Countries

United States; Austria; Belgium; Bulgaria; Canada; Czechia; France; Germany; Greece; Hungary; Israel; Italy; Netherlands; Poland; Romania; Russia; Serbia; Spain; Sweden; United Kingdom

References

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Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

PX-171-009

Identifier Type: -

Identifier Source: org_study_id