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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT01838512
Collaborator
(none)
2,555
Enrollment
190
Locations
195.5
Anticipated Duration (Months)
13.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2555 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
    Actual Study Start Date :
    Jun 13, 2012
    Anticipated Primary Completion Date :
    Sep 28, 2028
    Anticipated Study Completion Date :
    Sep 28, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

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

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

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

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

    Secondary Outcome Measures

    1. Treatment patterns of approved MM therapies as measured by the Response Rate for participants with RRMM [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 [From study index date until the enrollment date, assessed up to 8 years]

    3. Healthcare resource utilization (HCRU) for participants with RRMM [Up to 5 years]

    4. Healthcare resource utilization (HCRU) for participants with NDMM [Up to 8 years]

    5. Healthcare resource utilization (HCRU) for participants with RRMM [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 [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 [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 [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 [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 [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 [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 [From start of initial therapy to questionnaire completion, assessed up to 8 years]

    13. Incidence of Adverse Events (AEs) for participants with RRMM [Up to 5 years]

    14. Incidence of Adverse Events (AEs) for participants with NDMM [Up to 8 years]

    Eligibility Criteria

    Criteria

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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Birmingham Alabama United States 35213
    2 Alabama Oncology Birmingham Alabama United States 35243
    3 Northwest Alabama Cancer Center PC Muscle Shoals Alabama United States 35661
    4 Local Institute Goodyear Arizona United States 85338
    5 Local Institution Anaheim California United States 92801
    6 Pacific Cancer Madical Center Anaheim California United States 92801
    7 East Valley Hematology And Oncology Medical Group Burbank California United States 91505
    8 Local Institution Corona California United States 92880
    9 The Oncology Institute Of Hope And Innovation Downey California United States 90241
    10 Compassionate Cancer Care Medical Group Fountain Valley California United States 92708
    11 Local Institute Los Angeles California United States 90013
    12 Local Institute Santa Rosa California United States 95403
    13 St Joseph Heritage Healthcare Santa Rosa California United States 95403
    14 MedStar Washington Hospital Center Washington District of Columbia United States 20010
    15 Florida Cancer Specialists & Research Institute Brooksville Florida United States 34613
    16 Local Institution Brooksville Florida United States 34613
    17 Michael and Dianne Bienes Cancer Center Fort Lauderdale Florida United States 33308
    18 Cancer Specialists of North Florida Jacksonville Florida United States 32256
    19 Local Institution Jacksonville Florida United States 32256
    20 Summit Cancer Care Savannah Georgia United States 31404
    21 Local Institute Valdosta Georgia United States 31602
    22 Pearlman Cancer Center Valdosta Georgia United States 31602
    23 Local Institution Skokie Illinois United States 60077
    24 SIU Simmons Cancer Institute Springfield Illinois United States 62794-9677
    25 Carle Cancer Center Urbana Illinois United States 61801-2594
    26 St. Vincent Anderson Regional Hospital Anderson Indiana United States 46016
    27 Indiana Blood and Marrow Transplantation LLC Indianapolis Indiana United States 46237
    28 Local Institution Indianapolis Indiana United States 46237
    29 Mercy Medical Center Des Moines Iowa United States 50314
    30 JENCC ACCRU Allianc Site Sioux City Iowa United States 51101
    31 Local Institute Sioux City Iowa United States 51101
    32 KentuckyOne Health and Oncology Associates Lexington Kentucky United States 40504
    33 Saint Joseph London London Kentucky United States 40741
    34 Local Institute Louisville Kentucky United States 40201
    35 Norton Cancer Institute Louisville Kentucky United States 40202
    36 Cancer Center of Acadiana at Lafayette General Health Lafayette Louisiana United States 70503
    37 Local Institution Lafayette Louisiana United States 70503
    38 Local Institution Shreveport Louisiana United States 71103
    39 Willis Knighton Cancer Center Shreveport Louisiana United States 71103
    40 Local Institution Minneapolis Minnesota United States 55404
    41 Minnesota Oncology Hematology, P.A. Woodbury Minnesota United States 55125
    42 University of Mississippi Medical Center Jackson Mississippi United States 39216
    43 Local Institute Southaven Mississippi United States 38671
    44 Local Institute Kansas City Missouri United States 64132
    45 Research Medical Center Kansas City Missouri United States 64132
    46 Montana Cancer Institute Foundation Missoula Missouri United States 59802
    47 Local Institute Saint Joseph Missouri United States 64501
    48 Local Institution Saint Louis Missouri United States 63110
    49 Washington University School Of Medicine-St Louis Saint Louis Missouri United States 63110
    50 Local Institution Springfield Missouri United States 65804
    51 Mercy Medical Research Institute Springfield Missouri United States 65804
    52 Local Institute Missoula Montana United States 59802
    53 Local Institute Missoula Montana United States 59807
    54 Cancer Partners of Nebraska Lincoln Nebraska United States 68510-2496
    55 Local Institute Omaha Nebraska United States 68124
    56 Oncology Hematology West, P.C. Omaha Nebraska United States 68124
    57 Bms Clinical Research Center Does Not Exist New Jersey United States 08690-3542
    58 Stony Brook University Hospital Stony Brook New York United States 11794
    59 Local Institute Cary North Carolina United States 27518
    60 Waverly Hematology Oncology Cary North Carolina United States 27518
    61 Gaston Hematology & Oncology Gastonia North Carolina United States 28054
    62 Local Institution Gastonia North Carolina United States 28054
    63 Gabrail Cancer Center Research Canton Ohio United States 44718
    64 Local Institute Canton Ohio United States 44718
    65 Local Institute Cleveland Ohio United States 44109-1900
    66 MetroHealth Medical Center Cleveland Ohio United States 44109
    67 Local Institute Tulsa Oklahoma United States 74136
    68 Tulsa Cancer Institute PLLC Tulsa Oklahoma United States 74146
    69 Local Institute Portland Oregon United States 97200
    70 Local Institute Pottstown Pennsylvania United States 19464
    71 Pottstown Hospital Tower Health - Oncology Pottstown Pennsylvania United States 19464
    72 Charleston Oncology Charleston South Carolina United States 29414
    73 Local Institute Charleston South Carolina United States 29414
    74 Local Institute Knoxville Tennessee United States 37920
    75 University of Tennessee Medical Center Knoxville Tennessee United States 37920
    76 Baptist Cancer Center Memphis Tennessee United States 38120
    77 Local Institution Memphis Tennessee United States 38120
    78 Local Institute Amarillo Texas United States 79106
    79 Texas Oncology - Amarillo Amarillo Texas United States 79106
    80 St. Joseph Health Cancer Center Bryan Texas United States 77802
    81 Local Institute Corpus Christi Texas United States 78350
    82 Local Institute Dallas Texas United States 75229
    83 Dallas Presbyterian Hospital - Texas Oncology PA Dallas Texas United States 75231
    84 Local Institute Dallas Texas United States 75231
    85 Local Institute Dallas Texas United States 75390
    86 UT Southwestern Medical Center Dallas Texas United States 75390
    87 Texas Oncology-Garland Garland Texas United States 75042
    88 Cancer Care Centers Of South Texas San Antonio Texas United States 78217
    89 Local Institute San Antonio Texas United States 78217
    90 Local Institute Sherman Texas United States 75090
    91 Texas Oncology - Denison Sherman Texas United States 75090
    92 Local Institute Seattle Washington United States 98101
    93 VA Puget Sound Health Care System Seattle Washington United States 98108
    94 Cancer Care Northwest Spokane Washington United States 99202
    95 Local Institute Spokane Washington United States 99202
    96 Local Institute Yakima Washington United States 98901
    97 Local Institute Yakima Washington United States 98902
    98 Yakima Valley Memorial Hospital Yakima Washington United States 98902
    99 Local Institution Toronto Ontario Canada M3M 0B2
    100 Local Institute Toronto Ontario Canada M4N 3M5
    101 Local Institution Toronto Ontario Canada M5G 2M9
    102 Local Institute Weston Ontario Canada M9N 1N8
    103 Local Institute Blois France
    104 Local Institution Cannes Cedex France 06414
    105 Local Institution Chalon sur Saone France 71100
    106 Local Institute Chalon sur Saone France
    107 Local Institute La Roche sur Yon France
    108 Local Institution La Roche-sur-yon Cedex 9 France 85925
    109 Local Institution Limoges France 87042
    110 Local Institute Limoges France
    111 Local Institution Meaux France 77100
    112 Local Institute Meaux France
    113 Local Institution Nantes France 44093
    114 Local Institute Nantes France
    115 Local Institution Perigueux France 24000
    116 Local Institute Rennes France 35033
    117 Local Institution Rennes France 35033
    118 Local Institute Heidelberg Baden-Württemberg Germany 69120
    119 Local Institute Hamm Nordrhein-Westfalen Germany 59071
    120 Local Institute Aschaffenburg Germany 63739
    121 Local Institution Aschaffenburg Germany 63739
    122 Local Institute Berlin Germany 10407
    123 Local Institution Berlin Germany 10407
    124 Local Institution Bielefeld Germany 33611
    125 Local Institution Bochum Germany 44787
    126 Local Institute Dresden Germany 01099
    127 Local Institution Dresden Germany 01307
    128 Local Institution Frankfurt-oder Germany 15236
    129 Local Institution Gelsenkirchen Germany 45879
    130 Local Institution Goslar Germany 38642
    131 Local Institution Hamm Germany 59071
    132 Local Institution Heidelberg Germany 69120
    133 Local Institution Kiel Germany 24116
    134 Local Institution Köln Germany 50674
    135 Local Institution Ludwigsburg Germany 71640
    136 Local Institute Magdeburg Germany 39104
    137 Local Institution Magdeburg Germany 39104
    138 Local Institution Muenchen Germany 81377
    139 Local Institution Mutlangen Germany 73557
    140 Local Institute München Germany
    141 Local Institution Oldenburg Germany 26121
    142 Local Institution Reutlingen Germany 72764
    143 Local Institution Rostock Germany 18057
    144 Local Institution Rostock Germany 18059
    145 Local Institute Rostock Germany
    146 Local Institution Traunstein Germany 83278
    147 Local Institution Wiesbaden Germany 65191
    148 Local Institute Pesaro Pesaro E Urbino Italy 61122
    149 Local Institute Ancona Italy 042002
    150 Local Institution Ancona Italy 60123
    151 Local Institute Ancona Italy 60126
    152 Local Institution Cagliari Italy 09121
    153 Local Institute Cagliari Italy B354
    154 Local Institution Firenze Italy 50134
    155 Local Institute Firenze Italy 50139
    156 Local Institute Lecce Italy 73100
    157 Local Institution Lecce Italy 73100
    158 Local Institution Messina Italy 98121
    159 Local Institution Messina Italy 98122
    160 Local Institute Milano Italy 20121
    161 Local Institution Milano Italy 20133
    162 Local Institute Napoli Italy 80136
    163 Local Institution Napoli Italy 80139
    164 Local Institution Pesaro Italy 61122
    165 Local Institution Pescara Italy 65124
    166 Local Institute Roma Italy 00161
    167 Local Institution Roma Italy 00161
    168 Local Institution Roma Italy 00189
    169 Local Institution Roma Italy 00189
    170 Local Institution San Giovanni Rotondo (FG) Italy 71013
    171 Local Institution Terni Italy 05100
    172 Local Institute Terni Italy 5100
    173 Local Institute Torino Italy 10126
    174 Local Institution Torino Italy 10126
    175 Local Institute Vicenza Italy 36100
    176 Local Institution Vicenza Italy 36100
    177 Local Institute Truro Cornwall United Kingdom TR1 3LJ
    178 Local Institution Harrow United Kingdom HA1 3UJ
    179 Local Institute Leeds United Kingdom LS9 7TF
    180 Local Institution Leeds United Kingdom LS97TF
    181 Local Institution Liverpool United Kingdom L7 8XP
    182 Local Institution Liverpool United Kingdom L7 8XP
    183 Local Institution Manchester United Kingdom 30115
    184 Local Institute Nottingham United Kingdom NG5 1PB
    185 Local Institution Nottingham United Kingdom NG5 1PB
    186 Local Institute Stafford United Kingdom ST16 3SA
    187 Local Institution Stafford United Kingdom ST16 3SA
    188 Local Institute Swansea United Kingdom SA2 8QA
    189 Local Institution Swansea United Kingdom SA2 8QA
    190 Local Institution Truro United Kingdom TR1 3LJ

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT01838512
    Other Study ID Numbers:
    • CA204-008
    First Posted:
    Apr 24, 2013
    Last Update Posted:
    May 6, 2022
    Last Verified:
    May 1, 2022
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of May 6, 2022