A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab and Pomalidomide Versus Daratumumab in Combination With Pomalidomide and Dexamethasone in Participants With Multiple Myeloma That Returns After Treatment or is Resistant to Treatment

Relapsed or Refractory Multiple Myeloma Clinical Trial

— MonumenTAL-3  

Official title:

A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455320
• Other study ID #: CR109082
• Secondary ID: 2021-000202-2264
• Status: Recruiting
• Phase: Phase 3
• Start date: October 13, 2022
• Est. completion date: September 30, 2029

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).

Description:

Overall rationale of the study is that combination treatments of talquetamab, daratumumab, pomalidomide and dexamethasone may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. The study is divided into 3 phases: screening, treatment (until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first), and posttreatment follow-up (until death, withdrawal of consent, loss to follow-up, or end of the study, whichever occurs first). Efficacy, safety (physical examinations, neurologic examinations, Eastern Cooperative Oncology Group [ECOG] performance status, clinical laboratory tests, vital signs, and AE monitoring), pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. Total duration of study will be up to 6 years 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 810
• Est. completion date: September 30, 2029
• Est. primary completion date: February 6, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented multiple myeloma as defined: a) Multiple myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria and b) Measurable disease at screening as defined by any of the following: i) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL) (central laboratory); ii) Urine M-protein level >= 200 milligram (mg) per 24 hours (central laboratory); iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum immunoglobulin free light chain >= 10 milligram per deciliter (mg/dL) (central laboratory), and abnormal serum immunoglobulin kappa lambda free light chain ratio

• Relapsed or refractory disease as defined by: i) Relapsed disease is defined as an initial response to prior treatment, followed by confirmed progressive disease by IMWG criteria greater than (>) 60 days after cessation of treatment; ii) Refractory disease is defined as less than (<) 25 percent (%) reduction in monoclonal paraprotein (M-protein) or confirmed progressive disease by IMWG criteria during previous treatment or less than or equal to (<=) 60 days after cessation of treatment

• Received at least 1 prior line of antimyeloma therapy including a proteasome inhibitor (PI) and lenalidomide. Participants who have received only 1 prior line of antimyeloma therapy must be considered lenalidomide-refractory (that is, have demonstrated progressive disease by IMWG criteria on or within 60 days of completion of lenalidomide-containing regimen). Participants who have received >=2 prior lines of antimyeloma therapy must be considered lenalidomide exposed

• Documented evidence of progressive disease based on investigator's determination of response by the IMWG criteria on or after their last regimen

• Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 at screening and immediately prior to the start of administration of study treatment

Exclusion Criteria:

• Contraindications or life-threatening allergies, hypersensitivity, or intolerance to study drug excipients

• Disease is considered refractory to an anti-cluster of differentiation 38 (CD38) monoclonal antibody as defined per IMWG consensus guidelines (progression during treatment or within 60 days of completing therapy with an anti-CD38 monoclonal antibody)

• Received prior pomalidomide therapy

• A maximum cumulative dose of corticosteroids to >=140 milligrams (mg) of prednisone or equivalent within 14-day period before the first dose of study drug

• Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

• Plasma cell leukemia (per IMWG criteria) at the time of screening, Waldenström's macroglobulinemia, polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes (POEMS syndrome), or primary amyloid light chain amyloidosis

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

Drug:
• Talquetamab
Talquetamab will be administered subcutaneously.
• Daratumumab
Daratumumab will be administered subcutaneously.
• Pomalidomide
Pomalidomide will be administered orally.
• Dexamethasone
Dexamethasone will be administered orally or intravenously.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel
Belgium	UZA	Edegem
Belgium	Virga Jessa Ziekenhuis	Hasselt
Belgium	CHC MontLegia	Liège
Belgium	Clinique Saint Pierre	Ottignies
Belgium	UCL Mont Godinne	Yvoir
Brazil	Fundacao Pio XII	Barretos
Brazil	Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte
Brazil	Hospitais Integradaos da Gavea S/A - DF Star	Brasilia
Brazil	Fundacao Universidade de Caxias do Sul	Caxias do Sul
Brazil	Liga Paranaense de Combate ao Cancer	Curitiba
Brazil	Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN	Florianopolis
Brazil	Liga Norte Riograndense Contra O Cancer	Natal
Brazil	Irmandade Santa Casa de Misericordia de Porto Alegre	Porto Alegre
Brazil	Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP	Ribeirão Preto
Brazil	Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)	Rio de Janeiro
Brazil	Hospital Sao Rafael	Salvador
Brazil	Fundacao Antonio Prudente A C Camargo Cancer Center	Sao Paulo
Brazil	Hospital Paulistano	Sao Paulo
Brazil	Instituto D Or de Pesquisa e Ensino (IDOR)	Sao Paulo
Brazil	Clinica Sao Germano	São Paulo
Brazil	Real e Benemerita Associacao Portuguesa de Beneficencia	São Paulo
Brazil	Sociedade Beneficente de Senhoras - Hospital Sírio Libanês	São Paulo
China	Beijing Chaoyang Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Peking University First Hospital	Beijing
China	The First Hospital of Jilin University	Changchun
China	The second Xiangya Hospital of Central South University	ChangSha
China	Sichuan Academy of Medical Science Sichuan Provincial People's Hospital	Chengdu
China	Fujian Medical University Union Hospital	Fuzhou
China	Guangdong Provincial People's Hospital	Guangzhou
China	Sun Yat-Sen University Cancer Center	Guangzhou
China	The First Affiliated Hospital Zhejiang University College of Medicine	Hangzhou
China	Nanjing Drum Tower Hospital	Nanjing
China	Shanghai Fourth People s Hospital	Shanghai
China	Tongji Hospital of Tongji University	Shanghai
China	Peking University Shenzhen Hospital	Shenzhen
China	First Affiliated Hospital SooChow University	Su Zhou
China	Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science	Tianjin
China	Tianjin cancer hospital	Tianjin
China	Tongji Hospital, Tongji Medical College of HUST	Wuhan
China	Henan Cancer Hospital	Zhengzhou
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Ostrava	Ostrava - Poruba
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Czechia	Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie	Praha 2
France	APHP - Hopital Henri Mondor	Creteil
France	CHU Dijon	Dijon
France	Centre Leon Berard	Lyon
France	CHU de Montpellier - Hopital Saint-Eloi	Montpellier Cedex 5
France	CHU de Nantes hotel Dieu	Nantes
France	CHU HOPITAL DE L'ARCHET - Hematology	Nice N/a
France	CHU Hopital Saint Antoine	Paris Cedex 12
France	CHRU - Hôpital du Haut Lévêque - Centre François Magendie	Pessac
France	Institut Universitaire du cancer de Toulouse-Oncopole	TOULOUSE Cedex 9
Germany	Charite Campus Benjamin Franklin	Berlin
Germany	Asklepios Klinik Altona	Hamburg
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Universitaetsklinikum Koelnt	Koeln
Germany	Universitaetsklinikum Leipzig	Leipzig
Germany	Universitätsmedizin der Johannes Gutenberg Universität	Mainz
Germany	Universitaetsklinikum Wuerzburg	Wuerzburg
Greece	Alexandra General Hospital of Athens	Athens Attica
Greece	Anticancer Hospital of Thessaloniki Theageneio	Thessaloniki
Greece	G Papanikolaou Hospital of Thessaloniki	Thessalonikis
Israel	Ha'Emek Medical Center	Afula
Israel	Shamir Medical Center (Assaf Harofeh)	Be'er Ya'akov
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Bnai Zion Medical Center	Haifa
Israel	Carmel Medical Center	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Galilee Medical Center	Nahariya
Israel	Beilinson medical center	Petah Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Ziv Medical Center	Safed
Israel	Sourasky (Ichilov) Medical Center	Tel Aviv
Italy	A.O. Universitaria Ospedali Riuniti di Ancona	Ancona
Italy	Policlinico di Bari	Bari
Italy	Azienda Ospedaliera Policlinico S. Orsola-Malpighi	Bologna
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Italy	PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania	Catania
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Italy	Azienda Ospedaliera Universitaria di Padova	Padova
Italy	Ospedale Villa Sofia-Cervello	Palermo
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Arcispedale Santa Maria Nuova - IRCCS	Reggio Emilia
Italy	Presidio Ospedaliero Santo Spirito in Sassia	Roma
Italy	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo
Italy	A.O.U. Città della Salute e della Scienza	Torino
Japan	Tokyo Medical and Dental University Hospital	Bunkyo Ku
Japan	Chiba Cancer Center	Chiba
Japan	Fukuoka University Hospital	Fukuoka
Japan	Ogaki Municipal Hospital	Gifu
Japan	Gunma University Hospital	Gunma
Japan	Kansai Medical University Hospital	Hirakata
Japan	Japanese Red Cross Society Himeji Hospital	Hyogo
Japan	Hyogo Medical University Hospital	Hyôgo
Japan	Shonan Kamakura General Hospital	Kamakura-shi
Japan	National Cancer Center Hospital East	Kashiwa
Japan	Dokkyo Medical University Saitama Medical Center	Koshigaya
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kyoto Kuramaguchi Medical Center	Kyoto
Japan	National Hospital Organization Matsumoto Medical Center	Matsumoto
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Hiroshima West Medical Center	Otake
Japan	Hokkaido University Hospital	Sapporo-shi
Japan	Tohoku University Hospital	Sendai
Japan	Iwate Medical University Hospital	Shiwa-gun
Japan	Osaka University Hospital	Suita-shi
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Jeonbuk National University Hospital	Jeonju-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Netherlands	Albert Schweitzer ziekenhuis-lokatie Dordwijk	Dordrecht
Netherlands	Maxima Medisch Centrum	Eindhoven
Netherlands	Erasmus MC	Rotterdam
Poland	Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza	Brzozow
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Pratia Onkologia Katowice	Katowice
Poland	Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach	Kielce
Poland	Szpital Uniwersytecki w Krakowie	Krakow
Poland	Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli	Lublin
Poland	Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii	Olsztyn
Poland	Uniwersytecki Szpital Kliniczny Nr 1 PUM im prof Tadeusza Sokolowskiego w Szczecinie	Szczecin
Poland	Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu	Torun
Poland	Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy	Warszawa
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw
Spain	Hosp. Univ. Germans Trias I Pujol	Badalona
Spain	Hosp Clinic de Barcelona	Barcelona
Spain	Hosp. de La Santa Creu I Sant Pau	Barcelona
Spain	Hosp. Univ. Vall D Hebron	Barcelona
Spain	Hosp. Univ. Virgen de La Arrixaca	El Palmar, Murcia
Spain	Hosp. de Jerez de La Frontera	Jerez de la Frontera
Spain	Hosp. de Leon	Leon
Spain	Hosp. Univ. 12 de Octubre	Madrid
Spain	Hosp. Univ. de La Princesa	Madrid
Spain	Hosp. Univ. Hm Sanchinarro	Madrid
Spain	Hosp. Univ. Ramon Y Cajal	Madrid
Spain	Hosp. Virgen de La Victoria	Malaga
Spain	Clinica Univ. de Navarra	Pamplona
Spain	Hosp Clinico Univ de Salamanca	Salamanca
Spain	Hosp. Univ. de Canarias	San Cristóbal de La Laguna
Spain	Hosp. Univ. Dr. Peset	Valencia
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung City
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Turkey	Ankara University Medical Faculty	Ankara
Turkey	Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit	Ankara
Turkey	Liv Hospital Ankara	Ankara
Turkey	Antalya Training And Research Hospital	Antalya
Turkey	Medipol Mega University Hospital	Istabul
Turkey	Istanbul University Cerrahpasa Medical Faculty	Istanbul
Turkey	Istanbul University Istanbul Medical Faculty	Istanbul
Turkey	Dokuz Eylul University Medical Faculty	Izmir
Turkey	On Dokuz Mayis University Medical Faculty	Samsun
United Kingdom	Blackpool Victoria Hospital	Blackpool
United Kingdom	Ninewells Hospital & Medical School	Dundee
United Kingdom	Hammersmith Hospital	London
United Kingdom	Newcastle Freeman Hospital	Newcastle Upon Tyne
United Kingdom	Nottingham City Hospital	Nottingham
United Kingdom	University Hospitals Plymouth NHS Trust	Plymouth
United Kingdom	Royal Marsden Hospital	Sutton
United Kingdom	New Cross Hospital	Wolverhampton
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Johns Hopkins University	Baltimore	Maryland
United States	Boston University Medical Center	Boston	Massachusetts
United States	Massachusetts General	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Levine Cancer Institute, Carolinas HealthCare System	Charlotte	North Carolina
United States	Novant Health	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University Of Illinois	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	OhioHealth	Columbus	Ohio
United States	The Ohio State University Wexner Medical Center - James Cancer Hospital	Columbus	Ohio
United States	Memorial Healthcare System	Hollywood	Florida
United States	Houston Methodist Hospital	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Joe Arrington Cancer Research Treatment Center	Lubbock	Texas
United States	Baptist Cancer Center	Memphis	Tennessee
United States	University of Miami Health System	Miami	Florida
United States	University Of Minnesota	Minneapolis	Minnesota
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Ochsner Health System	New Orleans	Louisiana
United States	Tulane University Hospital & Clinics	New Orleans	Louisiana
United States	NYU Langone Health	New York	New York
United States	Norwalk Hospital-oncology	Norwalk	Connecticut
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University - Massey Cancer Center	Richmond	Virginia
United States	Washington University School Of Medicine	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	SUNY Upstate Medical University	Syracuse	New York
United States	The University of Arizona Cancer Center	Tucson	Arizona
United States	George Washington University	Washington	District of Columbia
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	University of Kansas	Westwood	Kansas
United States	Novant Health	Winston-Salem	North Carolina
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  China,  Czechia,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	PFS is defined as time from the date of randomization to the first documentation of disease progression, or death due to any cause, whichever is reported first.	Up to 6 years 6 months
Secondary	Overall Response (Partial Response [PR] or Better)	Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria.	Up to 6 years 6 months
Secondary	Very Good Partial Response (VGPR) or Better Rate	VGPR or better rate is defined as the percentage of participants who achieve a VGPR or better according to IMWG response criteria.	Up to 6 years 6 months
Secondary	Complete Response (CR) or Better Rate	CR or better rate is defined as the percentage of participants who achieve CR or better according to IMWG response criteria.	Up to 6 years 6 months
Secondary	Overall Minimal Residual Disease (MRD) Negative CR	MRD-negative CR is defined as proportion of participants with CR or stringent CR who achieve MRD negativity at a threshold of 10^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy.	Up to 6 years 6 months
Secondary	Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of the participant's death.	Up to 6 years 6 months
Secondary	Progression-free Survival on Next-line Therapy (PFS2)	PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as progressive disease as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.	Up to 6 years 6 months
Secondary	Time to Next Therapy (TTNT)	TTNT is defined as the time from randomization to the start of subsequent antimyeloma treatment.	Up to 6 years 6 months
Secondary	Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to 6 years 6 months
Secondary	Number of Participants with AEs by Severity	Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).	Up to 6 years 6 months
Secondary	Serum Concentrations of Talquetamab	Serum concentrations of talquetamab will be reported.	Up to 6 years 6 months
Secondary	Serum Concentrations of Daratumumab	Serum concentrations of daratumumab will be reported.	Up to 6 years 6 months
Secondary	Number of Participants with Presence of Anti-Drug Antibodies (ADAs) to Talquetamab	Number of participants with presence ADAs to talquetamab will be reported.	Up to 6 years 6 months
Secondary	Number of Participants With Presence of Anti-Drug Antibodies (ADAs) to Daratumumab	Number of participants with presence of ADAs to daratumumab will be reported.	Up to 6 years 6 months
Secondary	Time to Worsening in Symptoms, Functioning, and Overall Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)	The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC-QLQ-C30).	Up to 6 years 6 months
Secondary	Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c	The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed--length short form derived from the PROMIS Physical Function item bank.	Up to 6 years 6 months
Secondary	Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30	Time to worsening in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.	Up to 6 years 6 months
Secondary	Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE	The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.	Up to 6 years 6 months
Secondary	Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)	The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.	Up to 6 years 6 months
Secondary	Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)	The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.	Up to 6 years 6 months
Secondary	Change From Baseline in Symptoms, Functioning, and Overall HRQoL as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q)	The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30.	Baseline up to 6 years 6 months
Secondary	Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PROMIS Short Form Version 2.0 -Physical Functioning 8c	The Patient-reported Outcomes Measurement Information System (PROMIS) Short Form Version 2.0 -Physical Function 8c is an 8-item fixed-length short form derived from the PROMIS Physical Function item bank.	Baseline up to 6 years 6 months
Secondary	Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30	Change from baseline in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 will be reported.	Baseline up to 6 years 6 months
Secondary	Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by PRO-CTCAE	The National Cancer Institute's (NCI) PRO-CTCAE is an item library of common AEs experienced by people with cancer that are appropriate for self-reporting of treatment tolerability.	Baseline up to 6 years 6 months
Secondary	Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by EuroQol Five Dimension Questionnaire 5-Level (EQ-5D-5L)	The EQ-5D-5L is a generic measure of health status. For purposes of this study, the EQ-5D-5L will be used to generate utility scores for use in cost-effectiveness analyses.	Baseline up to 6 years 6 months
Secondary	Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by Patient Global Impression - Severity (PGI-S)	The PGI-S will be used as an anchor, external criterion, to determine meaningful change in scores for the MySIm-Q and PROMIS SF PF 8c in this population.	Baseline up to 6 years 6 months

External Links

•   Click here to learn more about the 64407564MMY3002 (MonumenTAL-3) trial