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JOURNAL ONKOLOGIE – STUDIE

Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)

Rekrutierend

NCT-Nummer:
NCT01838512

Studienbeginn:
Juni 2012

Letztes Update:
09.08.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Multiple Myeloma, Neoplasms, Plasma Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Bristol-Myers Squibb

Collaborator:
-

Studienleiter

Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb

Kontakt

BMS Study Connect Contact Center www.BMSStudyConnect.com
Kontakt:
Phone: 855-907-3286
E-Mail: Clinical.Trials@bms.com» Kontaktdaten anzeigen
First line of the email MUST contain NCT # and Site #

Studienlocations
(3 von 198)

Local Institute
69120 Heidelberg
(Baden-Württemberg)
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Local Institute
59071 Hamm
(Nordrhein-Westfalen)
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Local Institute
63739 Aschaffenburg
(Bayern)
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Local Institution - 0072
63739 Aschaffenburg
(Bayern)
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Local Institution - 0068
10407 Berlin
(Berlin)
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Local Institution - 0081
33611 Bielefeld
(Nordrhein-Westfalen)
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Local Institution
44787 Bochum
(Nordrhein-Westfalen)
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Local Institution - 0069
01307 Dresden
(Sachsen)
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Local Institution - 0082
01307 Dresden
(Sachsen)
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Local Institution - 0077
15236 Frankfurt-oder
(Brandenburg)
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Local Institution - 0084
45879 Gelsenkirchen
(Nordrhein-Westfalen)
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Local Institution - 0089
38642 Goslar
(Niedersachsen)
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Local Institution - 0070
59071 Hamm
(Nordrhein-Westfalen)
GermanyAbgeschlossen» Google-Maps
Local Institution - 0071
69120 Heidelberg
(Baden-Württemberg)
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Local Institution - 0088
24116 Kiel
(Schleswig-Holstein)
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Local Institution - 0087
50674 Köln
(Nordrhein-Westfalen)
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Local Institution - 0076
71640 Ludwigsburg
(Baden-Württemberg)
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Local Institute
39104 Magdeburg
(Sachsen-Anhalt)
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Local Institution - 0067
39104 Magdeburg
(Sachsen-Anhalt)
GermanyAbgeschlossen» Google-Maps
Local Institution - 0073
81377 Muenchen
(Bayern)
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Local Institution - 0079
73557 Mutlangen
(Baden-Württemberg)
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Local Institution - 0080
26121 Oldenburg
(Niedersachsen)
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Local Institution - 0075
72764 Reutlingen
(Baden-Württemberg)
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Local Institution - 0074
18057 Rostock
(Mecklenburg-Vorpommern)
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Local Institution - 0086
18059 Rostock
(Mecklenburg-Vorpommern)
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Local Institute
Rostock
(Mecklenburg-Vorpommern)
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Local Institution - 0078
83278 Traunstein
(Bayern)
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Local Institution - 0085
65191 Wiesbaden
(Hessen)
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Local Institution - 0021
35243 Birmingham
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Local Institution - 0013
35661 Muscle Shoals
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Local Institution - 0023
92801 Anaheim
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Local Institution - 0045
91505 Burbank
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Local Institution - 0048
90241 Downey
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Local Institution - 0052
92708 Fountain Valley
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Local Institution - 0051
95403 Santa Rosa
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Local Institution - 0057
20010 Washington
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Florida Cancer Specialists & Research Institute
34613 Brooksville
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Local Institution - 0044
33308 Fort Lauderdale
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Local Institution - 0017
32256 Jacksonville
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Local Institution
32256 Jacksonville
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Local Institution - 0046
31404 Savannah
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Local Institution - 0047
31602 Valdosta
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Local Institution - 0041
62794-9677 Springfield
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Local Institution - 0012
61801 Urbana
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Local Institution - 0058
46016 Anderson
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Local Institution - 0011
46237 Indianapolis
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Local Institution
46237 Indianapolis
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Local Institution - 0061
50314 Des Moines
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Local Institution - 0018
51101 Sioux City
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Local Institution - 0062
40504 Lexington
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Local Institution - 0064
40741 London
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Local Institution - 0042
40202 Louisville
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Cancer Center of Acadiana at Lafayette General Health
70503 Lafayette
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Local Institution - 0009
71103 Shreveport
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Local Institution - 0030
55125 Woodbury
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Local Institution - 0059
39216 Jackson
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Local Institution - 0050
64132 Kansas City
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Local Institution - 0037
59802 Missoula
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Local Institution - 0015
63110 Saint Louis
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Local Institution - 0020
65804 Springfield
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Local Institution - 0060
68510-2496 Lincoln
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Local Institution - 0024
68124 Omaha
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Local Institution - 008
08690-3542 Does Not Exist
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Local Institution - 0049
11794 Stony Brook
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Local Institution - 0033
27518 Cary
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Local Institution - 0010
28054 Gastonia
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Local Institution - 0022
44718 Canton
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Local Institute
44109-1900 Cleveland
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Local Institution - 0019
44109 Cleveland
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Tulsa Cancer Institute PLLC
74146 Tulsa
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Local Institution - 0043
19464 Pottstown
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Local Institution - 0016
29414 Charleston
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Local Institution - 0038
37920 Knoxville
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Local Institution - 0035
38120 Memphis
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Local Institution - 0029
79106 Amarillo
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Local Institution - 0063
77802 Bryan
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Local Institute
78350 Corpus Christi
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Local Institution - 0025
75231 Dallas
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Local Institution - 0014
75390 Dallas
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Local Institution - 0032
75042 Garland
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Local Institution - 0027
78217 San Antonio
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Local Institution - 0028
75090 Sherman
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Local Institution - 0039
98108 Seattle
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Local Institution - 0026
99202 Spokane
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Local Institution - 0031
98902 Yakima
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Local Institution - 0106
06414 Cannes Cedex
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Local Institution - 0099
71100 Chalon sur Saone
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Local Institution - 0100
85925 La Roche-sur-yon Cedex 9
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Local Institution - 0122
71013 San Giovanni Rotondo (FG)
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Local Institution - 0098
HA1 3UJ Harrow
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Local Institution - 0092
LS97TF Leeds
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Local Institution - 0091
L7 8XP Liverpool
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Local Institution - 0097
30115 Manchester
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Local Institution - 0095
NG5 1PB Nottingham
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Local Institution - 0096
ST16 3SA Stafford
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Local Institution - 0093
SA2 8QA Swansea
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Local Institution - 0094
TR1 3LJ Truro
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Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to assess the clinical effectiveness of all approved

multiple myeloma (MM) therapies in the newly-diagnosed (NDMM) and the relapsed/refractory

MM (RRMM) settings in real-world clinical practice.

Ein-/Ausschlusskriterien

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please

visit www.BMSStudyConnect.com

Inclusion Criteria:

For RRMM participants who have received at least one prior line of therapy (LoT) for MM:

- Have documented progression from a prior LoT

- Participants who have initiated treatment with one of the following therapies within

90 days before consent for this study OR in the case where treatment has not yet

been initiated, documentation that the treatment strategy was determined before

consent for this study must be provided, and treatment must be initiated within 30

days after consent:

- IMiDs

- PIs

- Combination of IMiD + PI

- Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Akt

inhibitors, SINE, or CAR T-cell therapies)

For NDMM participants receiving frontline therapy:

- Eligible to receive frontline therapy for MM (no prior MM treatment)

- Participants who have initiated treatment for MM with one of the following therapies

within 90 days before consent for this study OR in the case where treatment has not

yet been initiated, documentation that the treatment strategy was determined before

consent for this study must be provided, and treatment must be initiated within 30

days after consent:

- IMiDs

- PIs

- Combination of IMiD + PI

- Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Akt

inhibitors, SINE, or CAR T-cell therapies)

Exclusion Criteria:

- Participants who are currently participating in a clinical trial for MM

- Participants who are currently receiving treatment for primary cancer other than MM

- Participants who are not willing or able to provide informed consent

- Participants who are incarcerated

- Participants under compulsory detention for treatment of a physical (eg, infectious)

or psychiatric illness

Other protocol-defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM) (Time Frame - Up to 5 years)

2. Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM) (Time Frame - Up to 8 years)

3. Progression-Free Survival (PFS) for participants with RRMM (Time Frame - Up to 5 years)

4. Progression-Free Survival (PFS) for participants with NDMM (Time Frame - Up to 8 years)

Secondary outcome:

1. Treatment patterns of approved MM therapies as measured by the Response Rate for participants with RRMM (Time Frame - From study index date until the enrollment date, assessed up to 5 years)

2. Treatment patterns of approved MM therapies as measured by the Response Rate for participants with NDMM (Time Frame - From study index date until the enrollment date, assessed up to 8 years)

3. Healthcare resource utilization (HCRU) for participants with RRMM (Time Frame - Up to 5 years)

4. Healthcare resource utilization (HCRU) for participants with NDMM (Time Frame - Up to 8 years)

5. Healthcare resource utilization (HCRU) for participants with RRMM (Time Frame - From the day of enrollment until death, withdrawal of consent, enrollment into a clinical trial for MM, loss to follow-up, or end of study, whichever comes first; assessed up to 60 months)

6. Healthcare resource utilization (HCRU) for participants with NDMM (Time Frame - From the day of enrollment until death, withdrawal of consent, enrollment into a clinical trial for MM, loss to follow-up, or end of study, whichever comes first; assessed up to 96 months)

7. Patient reported outcomes as measured by EQ-5D summary index for participants with RRMM (Time Frame - From start of initial therapy to questionnaire completion, assessed up to 5 years)

8. Patient reported outcomes as measured by EQ-5D summary index for participants with NDMM (Time Frame - From start of initial therapy to questionnaire completion, assessed up to 8 years)

9. Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with RRMM (Time Frame - From start of initial therapy to questionnaire completion, assessed up to 5 years)

10. Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with NDMM (Time Frame - From start of initial therapy to questionnaire completion, assessed up to 8 years)

11. Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with RRMM (Time Frame - From start of initial therapy to questionnaire completion, assessed up to 5 years)

12. Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with NDMM (Time Frame - From start of initial therapy to questionnaire completion, assessed up to 8 years)

13. Incidence of Adverse Events (AEs) for participants with RRMM (Time Frame - Up to 5 years)

14. Incidence of Adverse Events (AEs) for participants with NDMM (Time Frame - Up to 8 years)

Studien-Arme

  • Cohort 1
    Participants with relapsed/refractory multiple myeloma (RRMM) followed up for up to 5 years
  • Cohort 2
    Participants with newly-diagnosed multiple myeloma (NDMM) followed up for up to 8 years

Quelle: ClinicalTrials.gov


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