Clinical trial NCT01838512: Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
Official title: Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-04-24
Enrollment: 2555
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of two cohorts: Participants with relapsed/refractory (RR) multiple myeloma (MM) and those with newly-diagnosed (ND) multiple myeloma (MM).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM)
timeFrame: Up to 5 years
measure: Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM)
timeFrame: Up to 8 years
measure: Progression-Free Survival (PFS) for participants with RRMM
timeFrame: Up to 5 years
measure: Progression-Free Survival (PFS) for participants with NDMM
timeFrame: Up to 8 years
Secondary outcomes:
measure: Treatment patterns of approved MM therapies as measured by the Response Rate for participants with RRMM
timeFrame: From study index date until the enrollment date, assessed up to 5 years
measure: Treatment patterns of approved MM therapies as measured by the Response Rate for participants with NDMM
timeFrame: From study index date until the enrollment date, assessed up to 8 years
measure: Healthcare resource utilization (HCRU) for participants with RRMM
timeFrame: Up to 5 years
measure: Healthcare resource utilization (HCRU) for participants with NDMM
timeFrame: Up to 8 years
measure: Healthcare resource utilization (HCRU) for participants with RRMM
timeFrame: 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
measure: Healthcare resource utilization (HCRU) for participants with NDMM
timeFrame: 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
measure: Patient reported outcomes as measured by EQ-5D summary index for participants with RRMM
timeFrame: From start of initial therapy to questionnaire completion, assessed up to 5 years
measure: Patient reported outcomes as measured by EQ-5D summary index for participants with NDMM
timeFrame: From start of initial therapy to questionnaire completion, assessed up to 8 years
measure: Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with RRMM
timeFrame: From start of initial therapy to questionnaire completion, assessed up to 5 years
measure: Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with NDMM
timeFrame: From start of initial therapy to questionnaire completion, assessed up to 8 years
measure: Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with RRMM
timeFrame: From start of initial therapy to questionnaire completion, assessed up to 5 years
measure: Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with NDMM
timeFrame: From start of initial therapy to questionnaire completion, assessed up to 8 years
measure: Incidence of Adverse Events (AEs) for participants with RRMM
timeFrame: Up to 5 years
measure: Incidence of Adverse Events (AEs) for participants with NDMM
timeFrame: Up to 8 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution
state: Alabama
city: Birmingham
country: United States
facility: Local Institution - 0021
state: Alabama
city: Muscle Shoals
country: United States
facility: Local Institution - 0013
state: Alabama
city: Goodyear
country: United States
facility: Local Institute
state: Arizona
city: Anaheim
country: United States
facility: Local Institution - 0023
state: California
city: Anaheim
country: United States
facility: Local Institution
state: California
city: Burbank
country: United States
facility: Local Institution - 0045
state: California
city: Corona
country: United States
facility: Local Institution
state: California
city: Downey
country: United States
facility: Local Institution - 0048
state: California
city: Fountain Valley
country: United States
facility: Local Institution - 0052
state: California
city: Los Angeles
country: United States
facility: Local Institute
state: California
city: Santa Rosa
country: United States
facility: Local Institute
state: California
city: Santa Rosa
country: United States
facility: Local Institution - 0051
state: California
city: Washington
country: United States
facility: Local Institution - 0057
state: District of Columbia
city: Brooksville
country: United States
facility: Florida Cancer Specialists & Research Institute
state: Florida
city: Brooksville
country: United States
facility: Local Institution
state: Florida
city: Fort Lauderdale
country: United States
facility: Local Institution - 0044
state: Florida
city: Jacksonville
country: United States
facility: Local Institution - 0017
state: Florida
city: Jacksonville
country: United States
facility: Local Institution
state: Florida
city: Savannah
country: United States
facility: Local Institution - 0046
state: Georgia
city: Valdosta
country: United States
facility: Local Institute
state: Georgia
city: Valdosta
country: United States
facility: Local Institution - 0047
state: Georgia
city: Skokie
country: United States
facility: Local Institution
state: Illinois
city: Springfield
country: United States
facility: Local Institution - 0041
state: Illinois
city: Urbana
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facility: Local Institution - 0012
state: Illinois
city: Anderson
country: United States
facility: Local Institution - 0058
state: Indiana
city: Indianapolis
country: United States
facility: Local Institution - 0011
state: Indiana
city: Indianapolis
country: United States
facility: Local Institution
state: Indiana
city: Des Moines
country: United States
facility: Local Institution - 0061
state: Iowa
city: Sioux City
country: United States
facility: Local Institute
state: Iowa
city: Sioux City
country: United States
facility: Local Institution - 0018
state: Iowa
city: Lexington
country: United States
facility: Local Institution - 0062
state: Kentucky
city: London
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facility: Local Institution - 0064
state: Kentucky
city: Louisville
country: United States
facility: Local Institute
state: Kentucky
city: Louisville
country: United States
facility: Local Institution - 0042
state: Kentucky
city: Lafayette
country: United States
facility: Cancer Center of Acadiana at Lafayette General Health
state: Louisiana
city: Lafayette
country: United States
facility: Local Institution
state: Louisiana
city: Shreveport
country: United States
facility: Local Institution - 0009
state: Louisiana
city: Shreveport
country: United States
facility: Local Institution
state: Louisiana
city: Minneapolis
country: United States
facility: Local Institution
state: Minnesota
city: Woodbury
country: United States
facility: Local Institution - 0030
state: Minnesota
city: Jackson
country: United States
facility: Local Institution - 0059
state: Mississippi
city: Southaven
country: United States
facility: Local Institute
state: Mississippi
city: Kansas City
country: United States
facility: Local Institute
state: Missouri
city: Kansas City
country: United States
facility: Local Institution - 0050
state: Missouri
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state: Missouri
city: Saint Joseph
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facility: Local Institute
state: Missouri
city: Saint Louis
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facility: Local Institution - 0015
state: Missouri
city: Saint Louis
country: United States
facility: Local Institution
state: Missouri
city: Springfield
country: United States
facility: Local Institution - 0020
state: Missouri
city: Springfield
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facility: Local Institution
state: Missouri
city: Missoula
country: United States
facility: Local Institute
state: Montana
city: Missoula
country: United States
facility: Local Institute
state: Montana
city: Lincoln
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facility: Local Institution - 0060
state: Nebraska
city: Omaha
country: United States
facility: Local Institute
state: Nebraska
city: Omaha
country: United States
facility: Local Institution - 0024
state: Nebraska
city: Does Not Exist
country: United States
facility: Local Institution - 008
state: New Jersey
city: No City Provided
country: United States
facility: Generic Country - Canada
state: New Jersey
city: No City Provided
country: United States
facility: Generic Country - France
state: New Jersey
city: No City Provided
country: United States
facility: Generic Country - Germany
state: New Jersey
city: No City Provided
country: United States
facility: Generic Country - Italy
state: New Jersey
city: No City Provided
country: United States
facility: Generic Country - UK
state: New Jersey
city: No City Provided
country: United States
facility: Generic Country - USA
state: New Jersey
city: Stony Brook
country: United States
facility: Local Institution - 0049
state: New York
city: Cary
country: United States
facility: Local Institute
state: North Carolina
city: Cary
country: United States
facility: Local Institution - 0033
state: North Carolina
city: Gastonia
country: United States
facility: Local Institution - 0010
state: North Carolina
city: Gastonia
country: United States
facility: Local Institution
state: North Carolina
city: Canton
country: United States
facility: Local Institute
state: Ohio
city: Canton
country: United States
facility: Local Institution - 0022
state: Ohio
city: Cleveland
country: United States
facility: Local Institute
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 0019
state: Ohio
city: Tulsa
country: United States
facility: Local Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa Cancer Institute PLLC
state: Oklahoma
city: Portland
country: United States
facility: Local Institute
state: Oregon
city: Pottstown
country: United States
facility: Local Institute
state: Pennsylvania
city: Pottstown
country: United States
facility: Local Institution - 0043
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institute
state: South Carolina
city: Charleston
country: United States
facility: Local Institution - 0016
state: South Carolina
city: Knoxville
country: United States
facility: Local Institute
state: Tennessee
city: Knoxville
country: United States
facility: Local Institution - 0038
state: Tennessee
city: Memphis
country: United States
facility: Local Institution - 0035
state: Tennessee
city: Memphis
country: United States
facility: Local Institution
state: Tennessee
city: Amarillo
country: United States
facility: Local Institute
state: Texas
city: Amarillo
country: United States
facility: Local Institution - 0029
state: Texas
city: Bryan
country: United States
facility: Local Institution - 0063
state: Texas
city: Corpus Christi
country: United States
facility: Local Institute
state: Texas
city: Dallas
country: United States
facility: Local Institute
state: Texas
city: Dallas
country: United States
facility: Local Institute
state: Texas
city: Dallas
country: United States
facility: Local Institution - 0025
state: Texas
city: Dallas
country: United States
facility: Local Institute
state: Texas
city: Dallas
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facility: Local Institution - 0014
state: Texas
city: Garland
country: United States
facility: Local Institution - 0032
state: Texas
city: San Antonio
country: United States
facility: Local Institute
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0027
state: Texas
city: Sherman
country: United States
facility: Local Institute
state: Texas
city: Sherman
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state: Texas
city: Seattle
country: United States
facility: Local Institute
state: Washington
city: Seattle
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facility: Local Institution - 0039
state: Washington
city: Spokane
country: United States
facility: Local Institute
state: Washington
city: Spokane
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state: Washington
city: Yakima
country: United States
facility: Local Institute
state: Washington
city: Yakima
country: United States
facility: Local Institute
state: Washington
city: Yakima
country: United States
facility: Local Institution - 0031
state: Washington
city: Toronto
country: Canada
facility: Local Institution - 0065
state: Ontario
city: Toronto
country: Canada
facility: Local Institute
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0066
state: Ontario
city: Weston
country: Canada
facility: Local Institute
state: Ontario
city: Blois
country: France
facility: Local Institute
city: Cannes Cedex
country: France
facility: Local Institution - 0106
city: Chalon sur Saone
country: France
facility: Local Institution - 0099
city: Chalon sur Saone
country: France
facility: Local Institute
city: La Roche sur Yon
country: France
facility: Local Institute
city: La Roche-sur-yon Cedex 9
country: France
facility: Local Institution - 0100
city: Limoges
country: France
facility: Local Institution - 0104
city: Limoges
country: France
facility: Local Institute
city: Meaux
country: France
facility: Local Institution - 0105
city: Meaux
country: France
facility: Local Institute
city: Nantes
country: France
facility: Local Institution - 0102
city: Nantes
country: France
facility: Local Institute
city: Perigueux
country: France
facility: Local Institution - 0101
city: Rennes
country: France
facility: Local Institute
city: Rennes
country: France
facility: Local Institution - 0103
city: Heidelberg
country: Germany
facility: Local Institute
state: Baden-Württemberg
city: Hamm
country: Germany
facility: Local Institute
state: Nordrhein-Westfalen
city: Aschaffenburg
country: Germany
facility: Local Institute
city: Aschaffenburg
country: Germany
facility: Local Institution - 0072
city: Berlin
country: Germany
facility: Local Institute
city: Berlin
country: Germany
facility: Local Institution - 0068
city: Bielefeld
country: Germany
facility: Local Institution - 0081
city: Bochum
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institute
city: Dresden
country: Germany
facility: Local Institution - 0069
city: Dresden
country: Germany
facility: Local Institution - 0082
city: Frankfurt-oder
country: Germany
facility: Local Institution - 0077
city: Gelsenkirchen
country: Germany
facility: Local Institution - 0084
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country: Germany
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country: Germany
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country: Germany
facility: Local Institution - 0076
city: Magdeburg
country: Germany
facility: Local Institute
city: Magdeburg
country: Germany
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city: Muenchen
country: Germany
facility: Local Institution - 0073
city: Mutlangen
country: Germany
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city: München
country: Germany
facility: Local Institute
city: Oldenburg
country: Germany
facility: Local Institution - 0080
city: Reutlingen
country: Germany
facility: Local Institution - 0075
city: Rostock
country: Germany
facility: Local Institution - 0074
city: Rostock
country: Germany
facility: Local Institution - 0086
city: Rostock
country: Germany
facility: Local Institute
city: Traunstein
country: Germany
facility: Local Institution - 0078
city: Wiesbaden
country: Germany
facility: Local Institution - 0085
city: Pesaro
country: Italy
facility: Local Institute
state: Pesaro E Urbino
city: Ancona
country: Italy
facility: Local Institute
city: Ancona
country: Italy
facility: Local Institution - 0108
city: Ancona
country: Italy
facility: Local Institute
city: Cagliari
country: Italy
facility: Local Institution - 0119
city: Cagliari
country: Italy
facility: Local Institute
city: Firenze
country: Italy
facility: Local Institution - 0111
city: Firenze
country: Italy
facility: Local Institute
city: Lecce
country: Italy
facility: Local Institute
city: Lecce
country: Italy
facility: Local Institution - 0113
city: Messina
country: Italy
facility: Local Institution - 0124
city: Messina
country: Italy
facility: Local Institution - 0120
city: Milano
country: Italy
facility: Local Institute
city: Milano
country: Italy
facility: Local Institution - 0116
city: Napoli
country: Italy
facility: Local Institute
city: Napoli
country: Italy
facility: Local Institution - 0114
city: Pesaro
country: Italy
facility: Local Institution - 0115
city: Pescara
country: Italy
facility: Local Institution - 0121
city: Roma
country: Italy
facility: Local Institute
city: Roma
country: Italy
facility: Local Institution - 0109
city: Roma
country: Italy
facility: Local Institution - 0110
city: Roma
country: Italy
facility: Local Institution - 0118
city: Roma
country: Italy
facility: Local Institution
city: San Giovanni Rotondo (FG)
country: Italy
facility: Local Institution - 0122
city: Terni
country: Italy
facility: Local Institution - 0107
city: Terni
country: Italy
facility: Local Institute
city: Torino
country: Italy
facility: Local Institute
city: Torino
country: Italy
facility: Local Institution - 0112
city: Vicenza
country: Italy
facility: Local Institute
city: Vicenza
country: Italy
facility: Local Institution - 0117
city: Truro
country: United Kingdom
facility: Local Institute
state: Cornwall
city: Harrow
country: United Kingdom
facility: Local Institution - 0098
state: Greater London
city: Leeds
country: United Kingdom
facility: Local Institute
city: Leeds
country: United Kingdom
facility: Local Institution - 0092
city: Liverpool
country: United Kingdom
facility: Local Institution - 0091
city: Liverpool
country: United Kingdom
facility: Local Institution
city: Manchester
country: United Kingdom
facility: Local Institution - 0097
city: Nottingham
country: United Kingdom
facility: Local Institute
city: Nottingham
country: United Kingdom
facility: Local Institution - 0095
city: Stafford
country: United Kingdom
facility: Local Institute
city: Stafford
country: United Kingdom
facility: Local Institution - 0096
city: Swansea
country: United Kingdom
facility: Local Institute
city: Swansea
country: United Kingdom
facility: Local Institution - 0093
city: Truro
country: United Kingdom
facility: Local Institution - 0094
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: