AzTrials
AzTrials

Relapsed or Refractory Multiple MyelomaPhase 3ARROW2NCT03859427

A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

A Phase 3 study testing Carfilzomib, Lenalidomide and Dexamethasone in people with Relapsed or Refractory Multiple Myeloma, run by Amgen at 108 sites in 17 countries.

Completed

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

Official record
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Trial summary

Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Relapsed or Refractory Multiple Myeloma
What is being tested?
Carfilzomib, Lenalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
454 participants
Where
108 sitesin 17 countries
Study dates
8 May 2019to 31 Mar 2023
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Multiple myeloma with documented relapse or progression after most recent myeloma treatment. Subjects refractory to the most recent line of therapy are eligible, unless last treatment contained proteasome inhibitor (PI) or lenalidomide and dexamethasone. Refractory is defined as disease that is nonresponsive or progresses within 60 days of last therapy.
  • Subjects must have at least PR to at least 1 line of prior therapy.
  • Subjects must have received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation maintenance therapy will be considered as 1 line of therapy).
  • Prior therapy with a PI or the combination of lenalidomide and dexamethasone are allowed if the patient had at least a PR to the most recent treatment with a PI or lenalidomide and dexamethasone, neither PI or lenalidomide and dexamethasone containing treatment were ceased due to toxicity, the patient has not relapsed within 60 days of discontinuation of the PI or lenalidomide and dexamethasone containing treatment. A history of prior neuropathy is permitted if this was not grade 3, grade 4 or grade 2 with pain and if not resolved within the 14 days before enrollment, is less than or equal to grade 2 without pain. Patients are permitted to have received single agent lenalidomide as maintenance therapy within 60 days of enrollment.
  • Previous treatment with a lenalidomide and dexamethasone containing regimen is allowed, as long as the subject did not progress during the first 3 months after initiating lenalidomide and dexamethasone containing therapy.
  • Measurable disease with at least 1 of the following assessed within 21 days prior to randomization:
Show all 12Show fewer
  • Immunoglobulin G (IgG) multiple myeloma: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL
  • Immunoglobulin A (IgA), Immunoglobulin D (IgD), Immunoglobulin E (IgE) multiple myeloma: serum M-protein level ≥ 0.5 g/dL
  • Urine M-protein ≥ 200 mg per 24 hours
  • In subjects without measurable serum or urine M-protein, serum-free light chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 ≤ 2
  • Other inclusion criteria may apply

Who cannot join

  • Waldenström macroglobulinemia.
  • Multiple myeloma of Immunoglobulin M (IgM) subtype.
  • Plasma cell leukemia (> 2.0 × 10^9 /L circulating plasma cells by standard differential).
  • Uncontrolled hypertension, defined as a subject whose blood pressure is greater than or equal to 160 mmHg systolic or greater than or equal to 100 mmHg diastolic when taken in accordance with the European Society of Hypertension/European Society of Cardiology 2018 guidelines (Section 12.10; Williams et al, 2018).
  • Active congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, screening ECG with corrected QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization.
  • Calculated or measured creatinine clearance < 30 mL/min (calculation must be based on the Cockcroft and Gault formula) within 28 days prior to randomization.
  • Other exclusion criteria may apply

Trial locations and contacts

108 sites in 17 countries.

108 sites in 17 countries

Japan21 sites

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Japanese Red Cross Society Himeji Hospital

    Himeji-shi, Hyōgo, 670-8540

  • Hitachi Ltd Hitachi General Hospital

    Hitachi-shi, Ibaraki, 317-0077

  • Tesshokai Kameda General Hospital

    Kamogawa-shi, Chiba, 296-8602

  • Saitama Medical Center

    Kawagoe-shi, Saitama, 350-8550

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Hyogo College of Medicine Hospital

    Nishinomiya-shi, Hyōgo, 663-8501

  • Ogaki Municipal Hospital

    Ogaki-shi, Gifu, 503-8502

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192

  • Japanese Red Cross Osaka Hospital

    Osaka, Osaka, 543-8555

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511

  • National Hospital Organization Sendai Medical Center

    Sendai, Miyagi, 983-8520

  • National Hospital Organization Shibukawa Medical Center

    Shibukawa-shi, Gunma, 377-0280

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo, 150-8935

  • Osaka University Hospital

    Suita-shi, Osaka, 565-0871

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

  • Tochigi Cancer Center

    Utsunomiya, Tochigi, 320-0834

Other trials in Japan

United States12 sites

  • New York Oncology Hematology, PC

    Albany, New York, 12208

  • Oncology Hematology Care Inc

    Cincinnati, Ohio, 45242

  • Texas Oncology-Denton

    Denton, Texas, 76201

  • Rocky Mountain Cancer Centers Denver Midtown

    Denver, Colorado, 80218

  • US Oncology Research Investigational Products Center

    Fort Worth, Texas, 76177

  • Robert A Moss Oncology

    Fountain Valley, California, 92708

  • Oncology Consultants PA

    Houston, Texas, 77030

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut

    Plainville, Connecticut, 06062

  • Texas Oncology

    San Antonio, Texas, 78229

  • United States Oncology Regulatory Affairs Corporate Office

    The Woodlands, Texas, 77380

Other trials in United States

France10 sites

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44000

  • Centre Hospitalier Universitaire Archet 2

    Nice, 06202

  • Hopital Saint Louis

    Paris, 75010

  • Hopital Pitie-Salpetriere

    Paris, 75013

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

    Poitiers, 86021

  • Centre Hospitalier Universitaire de Rennes

    Rennes, 35033

  • Institut de Cancerologie Strasbourg

    Strasbourg, 67033

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059

  • Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Romania10 sites

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Fundeni Clinical Institute

    Bucharest, 022328

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Clinic Coltea

    Bucharest, 030171

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098

  • Institutul Oncologic Prof Dr Ion Chiricuta

    Cluj-Napoca, 400015

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Spitalul Clinic Dr Gavril Curteanu Oradea

    Oradea, 410469

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu, 550245

  • Spitalul Clinic Municipal de Urgenta Timisoara

    Timișoara, 300079

Other trials in Romania

Greece9 sites

  • University Hospital of Alexandroupolis

    Alexandroupoli, 68100

  • General Hospital Evangelismos

    Athens, 10676

  • Agios Savvas Anticancer Hospital

    Athens, 115 22

  • 251 General Airforce Hospital

    Athens, 11525

  • Alexandra Hospital

    Athens, 11528

  • Metropolitan Hospital

    Athens, 18547

  • General University Hospital of Patras Panagia i Voithia

    Pátrai, 26504

  • Theagenion Cancer Hospital of Thessaloniki

    Thessaloniki, 54007

  • General Hospital of Thessaloniki Georgios Papanikolaou

    Thessaloniki, 57010

Other trials in Greece

Turkey (Türkiye)7 sites

  • Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi

    Ankara, 06560

  • Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi

    Ankara, 06590

  • Istanbul Universitesi Istanbul Tip Fakultesi

    Istanbul, 34093

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • Istanbul Florence Nightingale Hastanesi

    Istanbul, 34387

  • Dokuz Eylul Universitesi Arastirma Uygulama Hastanesi

    Izmir, 35340

  • Erciyes Universitesi Tip Fakultesi Mehmet Kemal Dedeman Hematoloji-Onkoloji Hastanesi

    Kayseri, 38039

Other trials in Turkey (Türkiye)

Russia6 sites

  • Regional Clinical Hospital

    Krasnoyarsk, 660022

  • Moscow State Budget Healthcare Institution City clinical Hospital 52 of Moscow Healthcare Department

    Moscow, 123182

  • SBHI of Moscow city City clinical hospital na S P Botkin of Moscow city Healthcare department

    Moscow, 125284

  • SBHI of Republic of Karelia Republic Hosiptal n a V A Baranov

    Petrozavodsk, 185019

  • Federal centre of heart, blood and endocrinology Almazova

    Saint Petersburg, 197341

  • State Budget Educational Institution of High Professional Skills Samara State Medical University

    Samara, 443079

Other trials in Russia

Spain6 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Catalonia, 08916

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036

  • Hospital Universitari Son Espases

    Palma de Mallorca, Balearic Islands, 07010

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Clinico Universitario de Salamanca

    Salamanca, Castille and León, 37007

Other trials in Spain

Germany5 sites

  • Charité, Universitätsklinikum Berlin, Campus Benjamin Franklin

    Berlin, 12200

  • Universitatsklinikum Koln

    Cologne, 50924

  • Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden

    Dresden, 01307

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Johannes Gutenberg Universitaet Mainz

    Mainz, 55131

Other trials in Germany

Sweden5 sites

  • Falu Lasarett

    Falun, 791 82

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Hallands Sjukhus Halmstad

    Halmstad, 301 85

  • Sunderby Sjukhus

    Luleå, 971 80

  • Skanes Universitetssjukhus

    Lund, 221 85

Other trials in Sweden

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Bulgaria3 sites

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

    Plovdiv, 4002

  • University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

    Sofia, 1431

  • Specialized Hospital for Active Treatment of Hematology Diseases EAD

    Sofia, 1756

Other trials in Bulgaria

Finland3 sites

  • Helsingin Yliopistollinen Keskussairaala

    Helsinki, 00290

  • Oulun Yliopistollinen Sairaala

    Oulu, 90220

  • Turun Yliopistollinen Keskussairaala

    Turku, 20521

Other trials in Finland

Netherlands3 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Gelre Ziekenhuizen

    Apeldoorn, 7334 DZ

  • Spaarne Gasthuis

    Hoofddorp, 2134 TM

Other trials in Netherlands

Lithuania2 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

    Kaunas, 50009

  • Vilnius University Hospital Santaros Clinic Public Institution

    Vilnius, 08661

Other trials in Lithuania

Austria1 site

  • Universitaetsklinikum Salzburg

    Salzburg, 5020

Other trials in Austria

Slovakia1 site

  • Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda

    Bratislava, 851 07

Other trials in Slovakia

About this study

Official title: A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)

Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.

Keywords
Bone Marrow Cancer
Medical subject headings
Recurrence, Multiple Myeloma, Bone Marrow Neoplasms

What participants receive

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

  • CarfilzomibDrug

    Once weekly IV over 30 minutes on day 1, 8 and 15 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 day 1 and 56 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.

  • CarfilzomibDrug

    Twice weekly IV over 10 minutes on day 1, 2, 8, 9, 15 and 16 of each 28 day cycle. The dose will be 20 mg/m2 on cycle 1 days 1 and 2 and 27 mg/m2 beginning with cycle 1 day 8 and thereafter. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent.

  • LenalidomideDrug

    Once daily orally 25 mg days 1 to 21 of each cycle. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent

  • DexamethasoneDrug

    Once daily orally or by IV 40 mg days 1, 8 and 15 of each cycle. Also day 22 of cycles 1 to 9. 12 cycles or until progression, unacceptable toxicity, death, loss to follow up or withdrawal of consent

Study groups in NCT03859427
Study groupRoleWhat they receive
Carfilzomib once-weeklyActive comparatorCarfilzomib, lenalidomide, dexamethasone (KRd) regimen using once-weekly carfilzomib 56 mg/m2
Receives: Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone
Carfilzomib twice-weeklyActive comparatorCarfilzomib, lenalidomide, dexamethasone (KRd) regimen using twice-weekly carfilzomib 27 mg/m2
Receives: Drug: Carfilzomib; Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

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

  1. Overall Response Rate (ORR) Per International Myeloma Working Group Uniform Response Criteria (IMWG-URC)

    ORR was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, < 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level < 100 mg/24-hours). PR: ≥ 50% reduction of serum M-protein and reduction in 24-hours urinary M-protein by ≥ 90% or to < 200 mg/24-hours. The ORR 95% confidence intervals (CIs) were estimated using the Clopper-Pearson method.

    Measured: Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.

Secondary outcomes (12)

  1. Kaplan-Meier Estimate of Progression-free Survival (PFS) Rate at 12 Months

    PFS rate was defined as the percentage of participants without disease progression or death due to any cause at 12 months. The PFS rate at 12 months was estimated using the Kaplan-Meier method by Klein and Moeschberger (1997). 95% CIs were estimated using the method by Kalbfleisch and Prentice (1980). PFS data was censored for participants who met any one of the following: 1. no baseline/no post-baseline disease assessments; 2. starting new anti-myeloma therapy before documentation of progressive disease (PD) or death; 3. PD or death immediately after more than 1 consecutively missed disease assessment visit (PD or death immediately after > 63 days without disease assessment visit); 4. alive without documentation of PD; 5. lost to follow-up or withdrawn consent.

    Measured: 12 months

  2. Percentage of Participants Who Reported Convenience as Measured by the Patient-reported Convenience With Carfilzomib-dosing Schedule Question

    Patient-reported convenience was measured by the Patient-reported Convenience with Carfilzomib-dosing Schedule Question. The items in the questionnaire were categorized as 'Convenient', which included responses of 'Very Convenient' and 'Convenient', and 'Inconvenient' which included responses of 'Inconvenient' and 'Very Inconvenient'. The 95% CIs were estimated using the Clopper-Pearson method.

    Measured: Day 28 of Cycle 4

  3. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs were AEs starting on or after the first dose of any study drug, and up to 30 days of the last dose of any study drug, excluding AEs reported after End of Study date.

    Measured: Cycle 1 Day 1 up to end of Cycle 12 + 30 days, where each cycle was 28 days; median treatment duration (any study treatment) was 47.00 weeks in the twice-weekly KRd group and 47.14 weeks in the once-weekly KRd group

  4. Time to Response (TTR)

    TTR was defined as the time from randomization to the earliest date when confirmed sCR, CR, VGPR, or PR per IMWG-URC was first achieved.

    Measured: Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.

  5. Kaplan-Meier Estimate of Duration of Response (DOR)

    For participants who achieved a PR or better, i.e., sCR, CR, VGPR, or PR per IMWG-URC, the DOR was defined as the time from the earliest date when a PR or better was first achieved, and subsequently confirmed, to the earliest date of confirmed PD or death due to any cause. Median DOR was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. For those alive and who had not experienced PD by analysis time, DOR was censored for participants who met any one of the following: 1. no baseline/no post-baseline disease assessments; 2. starting new anti-myeloma therapy before documentation of PD or death; 3. PD or death immediately after more than 1 consecutively missed disease assessment visit (PD or death immediately after > 63 days without disease assessment visit); 4. alive without documentation of PD; 5. lost to follow-up or withdrawn consent.

    Measured: Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.

  6. Kaplan-Meier Estimate of Time to Progression (TTP)

    TTP was defined as the duration from randomization for the first documented disease progression per IMWG-UCR. Median TTP was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. TTP was censored for participants who had no confirmed PD at the last non non-evaluable (non-NE), post-baseline disease assessment or the earlier of the following, where applicable: 1. the last non-NE, post-baseline disease assessment prior to start of a new anti-myeloma treatment, or 2. the last non-NE, post-baseline assessment followed > 63 days later by disease progression; otherwise, at randomization.

    Measured: Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.

  7. Kaplan-Meier Estimate of Overall Survival (OS)

    OS was defined as the time from randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. Participants still alive or lost to follow-up or withdrawn consent from study by the analysis time were censored at the date on which the participant was last known to be alive.

    Measured: Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.

  8. Percentage of Participants Who Achieved Minimal Residual Disease Negative Complete Response (MRD[-]CR) by Independent Review Committee (IRC) Per IMWG-URC

    MRD[-]CR was defined as achievement of CR or better by IRC per IMWG-URC and achievement of MRD negativity as assessed by next generation sequencing method at a 10^-5 threshold over the duration of the study. The 95% CIs for percentages were estimated using the Clopper-Pearson method.

    Measured: Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.

  9. Percentage of Participants With Minimal Residual Disease Negativity (MRD[-]) by IRC Per IMWG-URC at 12 Months

    The percentage of participants with achievement of MRD[-] at 12 months (± 4 weeks) from randomization, as assessed by next generation sequencing method at a 10^-5 threshold. MRD negativity results from BM samples obtained at 8 to 13 months from randomization and prior to new anti-myeloma therapy or disease progression were considered in the calculation. The 95% CIs for percentages were estimated using the Clopper-Pearson method.

    Measured: Cycle 1 Day 1 up to 12 months (cycle = 28 days)

  10. Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ)-Core 30 (C30) Physical Functioning Scale

    The QLQ-C30 physical function is one of the functional domains of the EORTC QLQ-C30 self-reported instrument and the physical functioning score score ranges from 0-100 points, with 100 points indicating the best possible functioning. A positive change from baseline indicated an improvement in functioning.

    Measured: Baseline (Cycle 1 Day 1), Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose)

  11. Change From Baseline in EORTC QLQ-C30 Role Functioning Scale

    The QLQ-C30 role function is one of the functional domains of the EORTC QLQ-C30 self-reported instrument and the role functioning score ranges from 0-100 points, with 100 points indicating the best possible functioning. A positive change from baseline indicated an improvement in functioning.

    Measured: Baseline (Cycle 1 Day 1), Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose)

  12. Patient-reported Treatment Satisfaction as Measured by the Cancer Therapy Satisfaction Questionnaire (CTSQ)

    The CTSQ measures treatment satisfaction in individuals with cancer and includes a domain for satisfaction with therapy. The satisfaction with therapy scores ranges from 0 to 100 points, with 100 points indicating greatest satisfaction.

    Analysis was based on ANCOVA model. The dependent variable of the models were the scale scores measured at each visit. The model included effects of intercept, scale score measured at cycle 2 day 1 visit, treatment arm, and randomization stratification factors.

    Measured: Cycle 5 Day 1, Cycle 12 Day 1, and safety follow-up (30 days after last dose)

Timeline

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

  1. First posted1 Mar 2019
  2. Study start8 May 2019
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

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
454 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03859427
Sponsor's protocol ID
20180015
Acronym
ARROW2
Status last verified
Aug 2024
First submitted
14 Jan 2019
Last updated
13 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

  • Dimopoulos MA, Coriu D, Delimpasi S, Spicka I, Upchurch T, Fang B, Talpur R, Faber E, Beksac M, Leleu X. A.R.R.O.W.2: once- vs twice-weekly carfilzomib, lenalidomide, and dexamethasone in relapsed/refractory multiple myeloma. Blood Adv. 2024 Oct 8;8(19):5012-5021. doi: 10.1182/bloodadvances.2024013101.

    PubMed 39024542

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carfilzomib, Lenalidomide and Dexamethasone in people with Relapsed or Refractory Multiple Myeloma, run by Amgen at 108 sites in 17 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 12 inclusion and 7 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 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in Japan, United States, France, Romania, Greece and 12 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 18 Apr 2024). 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?

Overall Response Rate (ORR) Per International Myeloma Working Group Uniform Response Criteria (IMWG-URC) (time frame: Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.). 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 NCT03859427, which also lists 1 linked publication.

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 13 Aug 2024; AzTrials last refreshed its copy on 1 Nov 2026.

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