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

Last updated: January 28, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Myeloma

Cancer/tumors

Bone Neoplasm

Treatment

N/A

Clinical Study ID

NCT01838512
CA204-008
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 yetbeen initiated, documentation that the treatment strategy was determined beforeconsent for this study must be provided, and treatment must be initiated within 30days after consent:

  • IMiDs

  • PIs

  • Combination of IMiD + PI

  • Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Aktinhibitors, 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 therapieswithin 90 days before consent for this study OR in the case where treatment has notyet been initiated, documentation that the treatment strategy was determined beforeconsent for this study must be provided, and treatment must be initiated within 30days after consent:

  • IMiDs

  • PIs

  • Combination of IMiD + PI

  • Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Aktinhibitors, SINE, or CAR T-cell therapies)

Exclusion

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

Study Design

Total Participants: 2555
Study Start date:
June 13, 2012
Estimated Completion Date:
March 31, 2030

Connect with a study center

  • Local Institute

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • Local Institution - 0065

    Toronto, Ontario M3M 0B2
    Canada

    Site Not Available

  • Local Institution - 0066

    Toronto, Ontario M5G 2M9
    Canada

    Completed

  • Local Institute

    Weston, Ontario M9N 1N8
    Canada

    Active - Recruiting

  • Local Institute

    Blois,
    France

    Active - Recruiting

  • Local Institution - 0106

    Cannes Cedex, 06414
    France

    Site Not Available

  • Local Institute

    Chalon sur Saone,
    France

    Active - Recruiting

  • Local Institution - 0099

    Chalon sur Saone, 71100
    France

    Site Not Available

  • Local Institute

    La Roche sur Yon,
    France

    Active - Recruiting

  • Local Institution - 0100

    La Roche-sur-yon Cedex 9, 85925
    France

    Completed

  • Local Institute

    Limoges,
    France

    Active - Recruiting

  • Local Institution - 0104

    Limoges, 87042
    France

    Site Not Available

  • Local Institute

    Meaux,
    France

    Active - Recruiting

  • Local Institution - 0105

    Meaux, 77100
    France

    Site Not Available

  • Local Institute

    Nantes,
    France

    Active - Recruiting

  • Local Institution - 0102

    Nantes, 44093
    France

    Site Not Available

  • Local Institution - 0101

    Perigueux, 24000
    France

    Site Not Available

  • Local Institute

    Perpignan,
    France

    Site Not Available

  • Local Institute

    Rennes, 35033
    France

    Active - Recruiting

  • Local Institution - 0103

    Rennes, 35033
    France

    Site Not Available

  • Local Institute

    Heidelberg, Baden-Württemberg 69120
    Germany

    Active - Recruiting

  • Local Institute

    Hamm, Nordrhein-Westfalen 59071
    Germany

    Active - Recruiting

  • Local Institute

    Aschaffenburg, 63739
    Germany

    Active - Recruiting

  • Local Institution - 0072

    Aschaffenburg, 63739
    Germany

    Site Not Available

  • Local Institute

    Berlin, 10407
    Germany

    Active - Recruiting

  • Local Institution - 0068

    Berlin, 10407
    Germany

    Site Not Available

  • Local Institution - 0081

    Bielefeld, 33611
    Germany

    Site Not Available

  • Local Institution

    Bochum, 44787
    Germany

    Site Not Available

  • Local Institute

    Dresden, 01099
    Germany

    Active - Recruiting

  • Local Institution - 0069

    Dresden, 01307
    Germany

    Site Not Available

  • Local Institution - 0082

    Dresden, 01307
    Germany

    Site Not Available

  • Local Institution - 0077

    Frankfurt-oder, 15236
    Germany

    Site Not Available

  • Local Institution - 0084

    Gelsenkirchen, 45879
    Germany

    Site Not Available

  • Local Institution - 0089

    Goslar, 38642
    Germany

    Site Not Available

  • Local Institution - 0070

    Hamm, 59071
    Germany

    Completed

  • Local Institution - 0071

    Heidelberg, 69120
    Germany

    Site Not Available

  • Local Institution - 0088

    Kiel, 24116
    Germany

    Site Not Available

  • Local Institution - 0087

    Köln, 50674
    Germany

    Site Not Available

  • Local Institution - 0076

    Ludwigsburg, 71640
    Germany

    Site Not Available

  • Local Institute

    Magdeburg, 39104
    Germany

    Active - Recruiting

  • Local Institution - 0067

    Magdeburg, 39104
    Germany

    Completed

  • Local Institution - 0073

    Muenchen, 81377
    Germany

    Site Not Available

  • Local Institution - 0079

    Mutlangen, 73557
    Germany

    Site Not Available

  • Local Institute

    München,
    Germany

    Active - Recruiting

  • Local Institution - 0080

    Oldenburg, 26121
    Germany

    Site Not Available

  • Local Institution - 0075

    Reutlingen, 72764
    Germany

    Site Not Available

  • Local Institute

    Rostock,
    Germany

    Active - Recruiting

  • Local Institution - 0074

    Rostock, 18057
    Germany

    Site Not Available

  • Local Institution - 0086

    Rostock, 18059
    Germany

    Site Not Available

  • Local Institution - 0078

    Traunstein, 83278
    Germany

    Site Not Available

  • Local Institution - 0085

    Wiesbaden, 65191
    Germany

    Completed

  • Local Institute

    Pesaro, Pesaro E Urbino 61122
    Italy

    Active - Recruiting

  • Local Institute

    Ancona, 042002
    Italy

    Active - Recruiting

  • Local Institution - 0108

    Ancona, 60123
    Italy

    Site Not Available

  • Local Institute

    Cagliari, B354
    Italy

    Active - Recruiting

  • Local Institution - 0119

    Cagliari, 09121
    Italy

    Completed

  • Local Institute

    Firenze, 50139
    Italy

    Active - Recruiting

  • Local Institution - 0111

    Firenze, 50134
    Italy

    Completed

  • Local Institute

    Lecce, 73100
    Italy

    Active - Recruiting

  • Local Institution - 0113

    Lecce, 73100
    Italy

    Site Not Available

  • Local Institution - 0120

    Messina, 98122
    Italy

    Completed

  • Local Institution - 0124

    Messina, 98121
    Italy

    Site Not Available

  • Local Institute

    Milano, 20121
    Italy

    Active - Recruiting

  • Local Institution - 0116

    Milano, 20133
    Italy

    Completed

  • Local Institute

    Napoli, 80136
    Italy

    Active - Recruiting

  • Local Institution - 0114

    Napoli, 80139
    Italy

    Completed

  • Local Institution - 0115

    Pesaro, 61122
    Italy

    Completed

  • Local Institution - 0121

    Pescara, 65124
    Italy

    Completed

  • Local Institute

    Roma, 00161
    Italy

    Active - Recruiting

  • Local Institution

    Roma, 00189
    Italy

    Active - Recruiting

  • Local Institution - 0109

    Roma, 00161
    Italy

    Site Not Available

  • Local Institution - 0110

    Roma, 00161
    Italy

    Site Not Available

  • Local Institution - 0118

    Roma, 00189
    Italy

    Site Not Available

  • Local Institution - 0122

    San Giovanni Rotondo (FG), 71013
    Italy

    Site Not Available

  • Local Institute

    Terni, 5100
    Italy

    Active - Recruiting

  • Local Institution - 0107

    Terni, 05100
    Italy

    Completed

  • Local Institute

    Torino, 10126
    Italy

    Active - Recruiting

  • Local Institution - 0112

    Torino, 10126
    Italy

    Completed

  • Local Institute

    Vicenza, 36100
    Italy

    Active - Recruiting

  • Local Institution - 0117

    Vicenza, 36100
    Italy

    Completed

  • Local Institute

    Truro, Cornwall TR1 3LJ
    United Kingdom

    Active - Recruiting

  • Local Institution - 0098

    Harrow, Greater London HA1 3UJ
    United Kingdom

    Site Not Available

  • Local Institute

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • Local Institution - 0092

    Leeds, LS97TF
    United Kingdom

    Site Not Available

  • Local Institution

    Liverpool, L7 8XP
    United Kingdom

    Active - Recruiting

  • Local Institution - 0091

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Local Institution - 0097

    Manchester, 30115
    United Kingdom

    Site Not Available

  • Local Institute

    Nottingham, NG5 1PB
    United Kingdom

    Active - Recruiting

  • Local Institution - 0095

    Nottingham, NG5 1PB
    United Kingdom

    Completed

  • Local Institute

    Stafford, ST16 3SA
    United Kingdom

    Active - Recruiting

  • Local Institution - 0096

    Stafford, ST16 3SA
    United Kingdom

    Site Not Available

  • Local Institute

    Swansea, SA2 8QA
    United Kingdom

    Active - Recruiting

  • Local Institution - 0093

    Swansea, SA2 8QA
    United Kingdom

    Site Not Available

  • Local Institution - 0094

    Truro, TR1 3LJ
    United Kingdom

    Site Not Available

  • Local Institution

    Birmingham, Alabama 35213
    United States

    Active - Recruiting

  • Local Institution - 0021

    Birmingham, Alabama 35243
    United States

    Site Not Available

  • Local Institution - 0013

    Muscle Shoals, Alabama 35661
    United States

    Site Not Available

  • Local Institute

    Goodyear, Arizona 85338
    United States

    Active - Recruiting

  • Local Institution

    Anaheim, California 92801
    United States

    Active - Recruiting

  • Local Institution - 0023

    Anaheim, California 92801
    United States

    Completed

  • Pacific Cancer Madical Center

    Anaheim, California 92801
    United States

    Completed

  • East Valley Hematology And Oncology Medical Group

    Burbank, California 91505
    United States

    Completed

  • Local Institution - 0045

    Burbank, California 91505
    United States

    Completed

  • Local Institution

    Corona, California 92880
    United States

    Active - Recruiting

  • Local Institution - 0048

    Downey, California 90241
    United States

    Completed

  • The Oncology Institute Of Hope And Innovation

    Downey, California 90241
    United States

    Completed

  • Compassionate Cancer Care Medical Group

    Fountain Valley, California 92708
    United States

    Completed

  • Local Institution - 0052

    Fountain Valley, California 92708
    United States

    Completed

  • Local Institute

    Los Angeles, California 90013
    United States

    Active - Recruiting

  • Local Institute

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Local Institution - 0051

    Santa Rosa, California 95403
    United States

    Completed

  • St Joseph Heritage Healthcare

    Santa Rosa, California 95403
    United States

    Completed

  • Local Institution

    Whittier, California 90603
    United States

    Site Not Available

  • Local Institution - 0057

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Florida Cancer Specialists & Research Institute

    Brooksville, Florida 34613
    United States

    Site Not Available

  • Local Institution

    Brooksville, Florida 34613
    United States

    Active - Recruiting

  • Local Institution - 0044

    Fort Lauderdale, Florida 33308
    United States

    Completed

  • Michael and Dianne Bienes Cancer Center

    Fort Lauderdale, Florida 33308
    United States

    Completed

  • Local Institution

    Jacksonville, Florida 32256
    United States

    Active - Recruiting

  • Local Institution - 0017

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Local Institute

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Local Institution - 0046

    Savannah, Georgia 31404
    United States

    Site Not Available

  • Summit Cancer Care

    Savannah, Georgia 31404
    United States

    Site Not Available

  • Local Institute

    Valdosta, Georgia 31602
    United States

    Active - Recruiting

  • Local Institution - 0047

    Valdosta, Georgia 31602
    United States

    Completed

  • Pearlman Cancer Center

    Valdosta, Georgia 31602
    United States

    Completed

  • Local Institution

    Skokie, Illinois 60077
    United States

    Active - Recruiting

  • Local Institution - 0041

    Springfield, Illinois 62794-9677
    United States

    Completed

  • SIU Simmons Cancer Institute

    Springfield, Illinois 62794-9677
    United States

    Completed

  • Local Institution - 0012

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Local Institution - 0058

    Anderson, Indiana 46016
    United States

    Completed

  • St. Vincent Anderson Regional Hospital

    Anderson, Indiana 46016
    United States

    Completed

  • Indiana Blood and Marrow Transplantation LLC

    Indianapolis, Indiana 46237
    United States

    Completed

  • Local Institution

    Indianapolis, Indiana 46237
    United States

    Active - Recruiting

  • Local Institution - 0011

    Indianapolis, Indiana 46237
    United States

    Completed

  • Local Institution - 0061

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Local Institute

    Sioux City, Iowa 51101
    United States

    Active - Recruiting

  • Local Institution - 0018

    Sioux City, Iowa 51101
    United States

    Site Not Available

  • Local Institution - 0062

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Local Institution - 0064

    London, Kentucky 40741
    United States

    Site Not Available

  • Local Institute

    Louisville, Kentucky 40201
    United States

    Active - Recruiting

  • Local Institution - 0042

    Louisville, Kentucky 40202
    United States

    Completed

  • Norton Cancer Institute

    Louisville, Kentucky 40202
    United States

    Completed

  • Cancer Center of Acadiana at Lafayette General Health

    Lafayette, Louisiana 70503
    United States

    Site Not Available

  • Local Institution

    Lafayette, Louisiana 70503
    United States

    Active - Recruiting

  • Local Institution

    Shreveport, Louisiana 71103
    United States

    Active - Recruiting

  • Local Institution - 0009

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Local Institution

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Local Institution - 0030

    Woodbury, Minnesota 55125
    United States

    Completed

  • Minnesota Oncology Hematology, P.A.

    Woodbury, Minnesota 55125
    United States

    Completed

  • Local Institution - 0059

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Local Institute

    Southaven, Mississippi 38671
    United States

    Active - Recruiting

  • Local Institute

    Kansas City, Missouri 64132
    United States

    Active - Recruiting

  • Local Institution - 0050

    Kansas City, Missouri 64132
    United States

    Completed

  • Research Medical Center

    Kansas City, Missouri 64132
    United States

    Completed

  • Local Institution - 0037

    Missoula, Missouri 59802
    United States

    Completed

  • Montana Cancer Institute Foundation

    Missoula, Missouri 59802
    United States

    Completed

  • Local Institute

    Saint Joseph, Missouri 64501
    United States

    Active - Recruiting

  • Local Institution

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Local Institution - 0015

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Local Institution

    Springfield, Missouri 65804
    United States

    Active - Recruiting

  • Local Institution - 0020

    Springfield, Missouri 65804
    United States

    Completed

  • Mercy Medical Research Institute

    Springfield, Missouri 65804
    United States

    Completed

  • Local Institute

    Missoula, Montana 59802
    United States

    Active - Recruiting

  • Local Institution - 0060

    Lincoln, Nebraska 68510-2496
    United States

    Site Not Available

  • Local Institute

    Omaha, Nebraska 68124
    United States

    Active - Recruiting

  • Local Institution - 0024

    Omaha, Nebraska 68124
    United States

    Completed

  • Oncology Hematology West, P.C.

    Omaha, Nebraska 68124
    United States

    Completed

  • Bms Clinical Research Center

    Does Not Exist, New Jersey 08690-3542
    United States

    Site Not Available

  • Local Institution - 008

    Does Not Exist, New Jersey 08690-3542
    United States

    Site Not Available

  • Generic Country - Canada

    No City Provided, New Jersey 00000
    United States

    Active - Recruiting

  • Generic Country - France

    No City Provided, New Jersey 00000
    United States

    Active - Recruiting

  • Generic Country - Germany

    No City Provided, New Jersey 00000
    United States

    Active - Recruiting

  • Generic Country - Italy

    No City Provided, New Jersey 00000
    United States

    Active - Recruiting

  • Generic Country - UK

    No City Provided, New Jersey 00000
    United States

    Active - Recruiting

  • Generic Country - USA

    No City Provided, New Jersey 00000
    United States

    Active - Recruiting

  • Local Institute

    New York, New York 10065
    United States

    Site Not Available

  • Local Institution - 0049

    Stony Brook, New York 11794
    United States

    Completed

  • Stony Brook University Hospital

    Stony Brook, New York 11794
    United States

    Completed

  • Local Institute

    Cary, North Carolina 27518
    United States

    Active - Recruiting

  • Local Institution - 0033

    Cary, North Carolina 27518
    United States

    Completed

  • Waverly Hematology Oncology

    Cary, North Carolina 27518
    United States

    Completed

  • Gaston Hematology & Oncology

    Gastonia, North Carolina 28054
    United States

    Completed

  • Local Institution

    Gastonia, North Carolina 28054
    United States

    Active - Recruiting

  • Local Institution - 0010

    Gastonia, North Carolina 28054
    United States

    Completed

  • Gabrail Cancer Center Research

    Canton, Ohio 44718
    United States

    Completed

  • Local Institute

    Canton, Ohio 44718
    United States

    Active - Recruiting

  • Local Institution - 0022

    Canton, Ohio 44718
    United States

    Completed

  • Local Institute

    Cleveland, Ohio 44109-1900
    United States

    Active - Recruiting

  • Local Institution - 0019

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • Local Institute

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Tulsa Cancer Institute PLLC

    Tulsa, Oklahoma 74146
    United States

    Site Not Available

  • Local Institute

    Portland, Oregon 97200
    United States

    Active - Recruiting

  • Local Institute

    Pottstown, Pennsylvania 19464
    United States

    Active - Recruiting

  • Local Institution - 0043

    Pottstown, Pennsylvania 19464
    United States

    Site Not Available

  • Pottstown Hospital Tower Health - Oncology

    Pottstown, Pennsylvania 19464
    United States

    Site Not Available

  • Charleston Oncology

    Charleston, South Carolina 29414
    United States

    Completed

  • Local Institute

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Local Institution - 0016

    Charleston, South Carolina 29414
    United States

    Completed

  • Local Institute

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Local Institution - 0038

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • University of Tennessee Medical Center

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Baptist Cancer Center

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Local Institution

    Memphis, Tennessee 38120
    United States

    Active - Recruiting

  • Local Institution - 0035

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Local Institute

    Amarillo, Texas 79106
    United States

    Active - Recruiting

  • Local Institution - 0029

    Amarillo, Texas 79106
    United States

    Site Not Available

  • Local Institution - 0063

    Bryan, Texas 77802
    United States

    Site Not Available

  • Local Institute

    Corpus Christi, Texas 78350
    United States

    Active - Recruiting

  • Dallas Presbyterian Hospital - Texas Oncology PA

    Dallas, Texas 75231
    United States

    Completed

  • Local Institute

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Local Institution - 0014

    Dallas, Texas 75390
    United States

    Completed

  • Local Institution - 0025

    Dallas, Texas 75231
    United States

    Completed

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Completed

  • Local Institution - 0032

    Garland, Texas 75042
    United States

    Completed

  • Texas Oncology-Garland

    Garland, Texas 75042
    United States

    Completed

  • Cancer Care Centers Of South Texas

    San Antonio, Texas 78217
    United States

    Completed

  • Local Institute

    San Antonio, Texas 78217
    United States

    Active - Recruiting

  • Local Institution - 0027

    San Antonio, Texas 78217
    United States

    Completed

  • Local Institute

    Sherman, Texas 75090
    United States

    Active - Recruiting

  • Local Institution - 0028

    Sherman, Texas 75090
    United States

    Site Not Available

  • Local Institute

    Gig Harbor, Washington 98335
    United States

    Site Not Available

  • Local Institute

    Seattle, Washington 98101
    United States

    Active - Recruiting

  • Local Institution - 0039

    Seattle, Washington 98108
    United States

    Site Not Available

  • VA Puget Sound Health Care System

    Seattle, Washington 98108
    United States

    Site Not Available

  • Cancer Care Northwest

    Spokane, Washington 99202
    United States

    Completed

  • Local Institute

    Spokane, Washington 99202
    United States

    Active - Recruiting

  • Local Institution - 0026

    Spokane, Washington 99202
    United States

    Completed

  • Local Institute

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • Local Institute

    Yakima, Washington 98901
    United States

    Active - Recruiting

  • Local Institution - 0031

    Yakima, Washington 98902
    United States

    Completed

  • Yakima Valley Memorial Hospital

    Yakima, Washington 98902
    United States

    Completed

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