An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants

• Sponsor: Takeda (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02761187
• Collaborator: (none)
• Enrollment: 4,310
• Locations: 137
• Actual Duration (Months): 63
• Patients Per Site: 31.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to describe contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with newly diagnosed [ND] multiple myeloma (MM) and participants with relapsed/refractory [R/R] MM.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Other: No Intervention

Detailed Description

This is a prospective, non-interventional, observational study. This study will look at contemporary, real-world patterns of patient characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with MM. Participants will not be asked to change their routine clinical treatment. Participants will have to complete patient reported outcomes (PROs) surveys during on-site routine office visits.

The study will enroll approximately 4200 participants. Participants will be assigned to one of the following cohorts based upon the diagnosis of MM:

• ND MM within 3 months from initiation of treatment

• R/R MM who have received 1 to 3 prior lines of therapy

This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 8 years. Participants will be evaluated and followed-up for a period of at least 5 years, until death, are lost to follow-up, or the end of the study, whichever comes first.

Study Design

• Study Type: Observational
• Actual Enrollment: 4310 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Global, Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients - the INSIGHT - MM Study
• Actual Study Start Date: Jul 1, 2016
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Relapsed/refractory (R/R) MM Patients who have received 1 to 3 prior lines of therapy	Other: No Intervention
Newly diagnosed (ND) MM Patients within 3 months from initiation of treatment	Other: No Intervention

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Co-morbidities [Baseline up to 8 years]

2. Number of Participants Diagnosed with ND MM and R/R MM [Baseline up to 8 years]

3. Number of Participants Presenting Symptoms of ND MM and R/R MM [Baseline up to 8 years]

4. Sites of Disease [Baseline up to 8 years]

5. ECOG (Eastern Cooperative Oncology Group) Performance Status [Baseline up to 8 years]

   ECOG-PS measured on-therapy (time between first dose and last dose date with a 30-day lag) assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.

6. Frailty Index [Baseline up to 8 years]

   Frailty is defined as the combination of unintentional weight loss, exhaustion, low physical activity, slow walking speed, and muscular weakness.

7. Number of Participants Evaluated for Laboratory Test [Baseline up to 8 years]

   Laboratory tests include minimal residual disease (MRD), gene expression profiling (GEP), fluorescence in situ hybridization (FISH), and cytogenetic results, international staging system (ISS)/R-ISS stage, imaging results.

8. Duration for Treatment With Stem Cell Transplant [Baseline up to 8 years]

9. Number of Participants Reporting Overall Survival [Baseline up to 8 years]

10. Progression Status on Each Regimen [Baseline up to 8 years]

    Disease progression status was assessed by IMWG Response criteria

11. Response to Each Regimen [Baseline up to 8 years]

    Disease progression status was assessed by IMWG Response criteria

12. Time to Next therapy [Baseline up to 8 years]

13. Number of Participants With Stem Cell Transplant [Baseline up to 8 years]

Secondary Outcome Measures

1. Number of Treatment Combinations [Baseline up to 8 years]

2. Number of Treatment Sequencing [Baseline up to 8 years]

3. Number of Treatment Rechallenge [Baseline up to 8 years]

4. Number of Clinical Outcomes for Different Strategies [Baseline up to 8 years]

5. Number of Clinical Outcomes Between Continuous Treatment and Intermittent Treatment Strategy [Baseline up to 8 years]

6. Triggers of Treatment Initiation at Relapse Including Biochemical Progression or Symptomatic Progression [Baseline up to 8 years]

7. Reasons for Treatment Modifications [Baseline up to 8 years]

8. Health Related Quality of Life (HRQoL) Among MM Participants [Baseline up to 8 years]

9. Healthcare Resource Utilization (HRU) Among MM Participants [Baseline up to 8 years]

10. Associations Between Presentation and Disease Characteristics [Baseline up to 8 years]

11. Associations Between Choice Of Therapy and Clinical Outcomes [Baseline up to 8 years]

12. Number of Participants Reporting Discontinuation One or More Treatment-emergent Adverse Events [Baseline up to 8 years]

    Treatment discontinuation includes temporary and permanent discontinuation, drug modification, and second primary malignancies.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Is 18 years of age or older.

Is experiencing the following:

1. Newly diagnosed MM within 3 months from initiation of treatment with documented month and year of diagnosis, criteria met for diagnosis, stage, and MM-directed treatment history, including duration, or

2. Relapsed/refractory MM who have received 1 to 3 prior lines of therapy with documented data in the medical record regarding diagnosis (month and year), the regimens used in 1st, 2nd, and 3rd line as applicable, whether stem cell transplant was part of 1st, 2nd, and 3rd line of therapy, whether consolidation/maintenance was part of 1st, 2nd, and 3rd line of therapy, also whether investigational therapy/treated on a clinical trial was part of any of these regimens.

Is willing and able to sign informed consent to participate. Is willing and able to complete patient-reported outcomes (PROs) in accordance with local regulatory and data protection requirements.

Exclusion Criteria:

Is reporting to a site in this study for a second opinion (consultation only) or participants whose frequency of consult and follow-up are not adequate for quarterly electronic case report form (eCRF) completion.

Has participated in another study (observational or interventional) that prohibits participation in this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CARTI Cancer Center	Little Rock	Arkansas	United States	72205
2	University of Arkansas For Medical Sciences	Little Rock	Arkansas	United States	72205
3	University of California San Diego	La Jolla	California	United States	92093
4	St Joseph Heritage Healthcare	Santa Rosa	California	United States	95403
5	Rocky Mountain Cancer Centers (Williams) - USOR	Denver	Colorado	United States	80218
6	Poudre Valley Health System	Fort Collins	Colorado	United States	80528
7	George Washington University	Washington	District of Columbia	United States	20037
8	SCRI Florida Cancer Specialists East	Daytona Beach	Florida	United States	32117
9	SCRI Florida Cancer Specialists South	Fort Myers	Florida	United States	33916
10	SCRI Florida Cancer Specialists North	Saint Petersburg	Florida	United States	33705
11	Illinois Cancer Specialists (Niles) - USOR	Niles	Illinois	United States	60714
12	Indiana University	Indianapolis	Indiana	United States	46202
13	East Jefferson General Hospital	Metairie	Louisiana	United States	70006
14	Central Maine Medical Center	Lewiston	Maine	United States	04240
15	Maryland Oncology Hematology (Columbia) - USOR	Columbia	Maryland	United States	21044
16	Barbara Ann Karmanos Cancer Center	Detroit	Michigan	United States	48201
17	Park Nicollet Institute	Saint Louis Park	Minnesota	United States	55416
18	Central Care Cancer Center	Bolivar	Missouri	United States	65613
19	Kansas City VA Medical Center	Kansas City	Missouri	United States	64128
20	Washington University in St. Louis	Saint Louis	Missouri	United States	63110
21	Hunterdon Hematology Oncology	Flemington	New Jersey	United States	08822
22	San Juan Oncology Associates	Farmington	New Mexico	United States	87401
23	Saint Francis Hospital	East Hills	New York	United States	11576
24	Mount Sinai Medical Center	New York	New York	United States	10029
25	Levine Cancer Center	Charlotte	North Carolina	United States	28402
26	University of Cincinnati	Cincinnati	Ohio	United States	45220
27	Hematology Oncology Associates - USOR	Medford	Oregon	United States	97504
28	Northwest Cancer Specialists (Broadway) - USOR	Portland	Oregon	United States	97227
29	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
30	Veterans Affairs Pittsburgh Healthcare System	Pittsburgh	Pennsylvania	United States	15240
31	Greenville Health System Cancer Institute	Greenville	South Carolina	United States	29615
32	SCRI Tennessee Oncology Nashville	Nashville	Tennessee	United States	37203
33	Texas Oncology (Loop) - USOR	Amarillo	Texas	United States	79106
34	Texas Oncology (Loop) - USOR	Dallas	Texas	United States	92056
35	Texas Oncology (Loop) - USOR	El Paso	Texas	United States	79902
36	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
37	Texas Oncology (Loop) - USOR	Round Rock	Texas	United States	78681
38	Texas Oncology (Loop) - USOR	San Antonio	Texas	United States	78217
39	Yakima Valley Memorial Hospital North Star Lodge - USOR	Yakima	Washington	United States	98902
40	Berkeley Medical Center	Martinsburg	West Virginia	United States	25401
41	St Vincent Hospital	Green Bay	Wisconsin	United States	54307
42	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin	United States	53792
43	Aurora Health Care, Aurora Cancer Care	Milwaukee	Wisconsin	United States	53215
44	Grand Hopital de Charleroi asbl	Charleroi		Belgium	6000
45	UZ Gent	Gent		Belgium	9000
46	Hopital de Jolimont	Haine-Saint-Paul		Belgium	7100
47	UZ Leuven	Leuven		Belgium	3000
48	CHU de Liege	Liege		Belgium	4000
49	CHU UCL Namur asbl - Site Godinne	Yvoir		Belgium	5530
50	Unicamp Universidade Estadual de Campinas	Campinas		Brazil	13083-970
51	Centro de Pesquisas Oncologicas	Florianopolis		Brazil	88034
52	Hospital Das Clinicas Da Universidade Federal de Goias	Goiania		Brazil	74680-160
53	Universidade Federal Do Rio de Janeiro Hospital Universitario Clementino Fraga Filho	Rio de Janeiro		Brazil	21941-913
54	CEHON - Centro de Hematologia e Oncologia da Bahia Ltda	Salvador		Brazil	40110-090
55	Clinica Sao Germano	Sao Paulo		Brazil	04537-081
56	Hospital Israelita Albert Einstein	Sao Paulo		Brazil	05651-901
57	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo		Brazil	5403000
58	Peking Union Medical College Hospital	Beijing		China	100730
59	Peking University Peoples Hospital	Beijing		China
60	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou		China	310003
61	First Affiliated Hospital of Soochow University	Suzhou		China	215006
62	Fundacion Santa Fe de Bogota	Bogota		Colombia
63	Fundacion Oftalmologica de Santander Foscal	Floridablanca		Colombia
64	Hospital Pablo Tobon Uribe	Medellin		Colombia
65	Oncomedica SA	Monteria		Colombia
66	Centre Hospitalier de La Cote Basque	Bayonne		France	64109
67	Centre Hospitalier Le Mans	Le Mans		France	72000
68	Centre Hospitalier de Perigueux	Perigueux		France	24019
69	CHRU de Poitiers La Miletrie	Poitiers		France	86021
70	Centre Hospitalier Departemental de Vendee	Roche-sur-Yon		France	85000
71	CHU de Nancy-Hopital Brabois Adulte	Vandoeuvre-les-nancy		France	54211
72	Klinikum Chemnitz gGmbH	Chemnitz		Germany
73	Gefos - Gesellschaft fur onkologische Studien mbH	Dortmund		Germany
74	Universitatsklinikum Heidelberg	Heidelberg		Germany
75	Internistisch Hamatologische und Internistische Praxis	Herrsching am Ammersee		Germany
76	Institut fur Versorgungsforschung in der Onkologie GbR	Koblenz		Germany
77	Universitatsmedizin der Johannes Gutenberg-Universitat Mainz	Mainz		Germany
78	Mannheimer Onkologie Praxis	Mannheim		Germany
79	OnkoNet Marburg GmbH	Marburg		Germany
80	Onkologische Gemeinschaftspraxis Siegburg	Siegburg		Germany
81	Universitatsklinikum Tubingen	Tubingen		Germany
82	University Hospital of Alexandroupolis	Alexandroupoli		Greece	68100
83	Evangelismos General Hospital of Athens	Athens		Greece	10676
84	Alexandra Hospital	Athens		Greece	11525
85	University General Hospital of Ioannina	Ioannina		Greece	45500
86	University General Hospital of Larissa	Larisa		Greece	41110
87	University General Hospital of Patras	Patras		Greece	26500
88	HaEmek Medical Center	Afula		Israel	18371
89	Lady Davis Carmel Medical Center	Haifa		Israel	34362
90	Shaare Zedek Medical Center	Jerusalem		Israel
91	Meir Medical Center	Kefar-Sava		Israel	44281
92	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	64239
93	Assuta Medical Centers	Tel Aviv		Israel	69710
94	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi	Ancona		Italy	60020
95	Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi	Bologna		Italy	40138
96	Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele	Catania		Italy
97	Azienda Ospedaliera Universitaria Careggi	Firenze		Italy	50134
98	Azienda Ospedaliera Universitaria Federico II	Napoli		Italy
99	Azienda Policlinico Umberto I	Roma		Italy	00161
100	Azienda Ospedaliera Citta della Salute e della Scienza di Torino	Torino		Italy
101	Azienda Sanitaria Universitaria Integrata di Udine	Udine		Italy	33100
102	Nucleo Oncologico de Occidente S.C.	Guadalajara		Mexico	44670
103	Hematologica Alta Especialidad S.C.	Huixquilucan		Mexico
104	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Mexico City		Mexico	14000
105	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey		Mexico	64460
106	Hospital Clinic de Barcelona	Barcelona		Spain	8036
107	Hospital Universitario Virgen de Las Nieves	Granada		Spain	18014
108	Complejo Asistencial Universitario de Leon	Leon		Spain	24080
109	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
110	Hospital Universitario de Salamanca	Salamanca		Spain	37007
111	Hospital Universitari i Politecnic La Fe de Valencia	Valencia		Spain
112	Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital	Puzi	Chiayi County	Taiwan	613
113	Kaohsiung Medical University Hospital	Kaohsiung		Taiwan	807
114	Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital	Kaohsiung		Taiwan
115	China Medical University Hospital	Taichung City		Taiwan	40447
116	National Cheng Kung University Hospital	Tainan		Taiwan	70403
117	National Taiwan University Hospital	Taipei		Taiwan	10002
118	Cukurova Universitesi Tip Fakultesi Balcali Hastanesi	Adana		Turkey
119	Ankara University Medical Faculty Cebeci Hospital	Ankara		Turkey
120	Akdeniz University Medical Faculty	Antalya		Turkey
121	Johns Hopkins Medicine - Anadolu Saglik Merkezi	Gebze		Turkey
122	Ege Universitesi Tip Fakultesi Hastanesi	Istanbul		Turkey
123	Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi	Istanbul		Turkey
124	Dokuz Eylul University Medical Faculty	Izmir		Turkey
125	Erciyes Universitesi Tip Fakultesi Hastanesi	Kayseri		Turkey
126	Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi	Samsun		Turkey
127	Karadeniz Technical University Faculty of Medicine	Trabzon		Turkey
128	Leeds Teaching Hospitals NHS Trust	Leeds	West Yorkshire	United Kingdom	LS1 3EX
129	Royal United Hospital	Bath		United Kingdom
130	University Hospital Birmingham	Birmingham		United Kingdom	B15 2TH
131	Birmingham Heartlands Hospital	Birmingham		United Kingdom	B9 5SS
132	Royal Bournemouth Hospital	Bournemouth		United Kingdom	Bh7 7dw
133	Ninewells Hospital - PPDS	Dundee		United Kingdom	DD1 9SY
134	Leicester Royal Infirmary	Leicester		United Kingdom	LE1 5WW
135	Nottingham University Hospitals NHS Trust	Nottingham		United Kingdom	NG5 1PB
136	The Royal Marsden NHS Foundation Trust	Sutton		United Kingdom	SM2 5PT
137	Pinderfields General Hospital	Wakefield		United Kingdom	WF1 4DG

Sponsors and Collaborators

• Takeda

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02761187
• Other Study ID Numbers: NSMM-5001
• First Posted: May 4, 2016
• Last Update Posted: Feb 23, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Takeda: Drug Therapy
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Feb 23, 2022