Multiple Myeloma Clinical Trial
Official title:
Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
| NCT number | NCT01838512 |
| Other study ID # | CA204-008 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 13, 2012 |
| Est. completion date | September 28, 2028 |
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.
| Status | Recruiting |
| Enrollment | 2555 |
| Est. completion date | September 28, 2028 |
| Est. primary completion date | September 28, 2028 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Local Institute | Toronto | Ontario |
| Canada | Local Institution - 0065 | Toronto | Ontario |
| Canada | Local Institution - 0066 | Toronto | Ontario |
| Canada | Local Institute | Weston | Ontario |
| France | Local Institute | Blois | |
| France | Local Institution - 0106 | Cannes Cedex | |
| France | Local Institute | Chalon sur Saone | |
| France | Local Institution - 0099 | Chalon sur Saone | |
| France | Local Institute | La Roche sur Yon | |
| France | Local Institution - 0100 | La Roche-sur-yon Cedex 9 | |
| France | Local Institute | Limoges | |
| France | Local Institution - 0104 | Limoges | |
| France | Local Institute | Meaux | |
| France | Local Institution - 0105 | Meaux | |
| France | Local Institute | Nantes | |
| France | Local Institution - 0102 | Nantes | |
| France | Local Institution - 0101 | Perigueux | |
| France | Local Institute | Rennes | |
| France | Local Institution - 0103 | Rennes | |
| Germany | Local Institute | Aschaffenburg | |
| Germany | Local Institution - 0072 | Aschaffenburg | |
| Germany | Local Institute | Berlin | |
| Germany | Local Institution - 0068 | Berlin | |
| Germany | Local Institution - 0081 | Bielefeld | |
| Germany | Local Institution | Bochum | |
| Germany | Local Institute | Dresden | |
| Germany | Local Institution - 0069 | Dresden | |
| Germany | Local Institution - 0082 | Dresden | |
| Germany | Local Institution - 0077 | Frankfurt-oder | |
| Germany | Local Institution - 0084 | Gelsenkirchen | |
| Germany | Local Institution - 0089 | Goslar | |
| Germany | Local Institute | Hamm | Nordrhein-Westfalen |
| Germany | Local Institution - 0070 | Hamm | |
| Germany | Local Institute | Heidelberg | Baden-Württemberg |
| Germany | Local Institution - 0071 | Heidelberg | |
| Germany | Local Institution - 0088 | Kiel | |
| Germany | Local Institution - 0087 | Köln | |
| Germany | Local Institution - 0076 | Ludwigsburg | |
| Germany | Local Institute | Magdeburg | |
| Germany | Local Institution - 0067 | Magdeburg | |
| Germany | Local Institution - 0073 | Muenchen | |
| Germany | Local Institute | München | |
| Germany | Local Institution - 0079 | Mutlangen | |
| Germany | Local Institution - 0080 | Oldenburg | |
| Germany | Local Institution - 0075 | Reutlingen | |
| Germany | Local Institute | Rostock | |
| Germany | Local Institution - 0074 | Rostock | |
| Germany | Local Institution - 0086 | Rostock | |
| Germany | Local Institution - 0078 | Traunstein | |
| Germany | Local Institution - 0085 | Wiesbaden | |
| Italy | Local Institute | Ancona | |
| Italy | Local Institute | Ancona | |
| Italy | Local Institution - 0108 | Ancona | |
| Italy | Local Institute | Cagliari | |
| Italy | Local Institution - 0119 | Cagliari | |
| Italy | Local Institute | Firenze | |
| Italy | Local Institution - 0111 | Firenze | |
| Italy | Local Institute | Lecce | |
| Italy | Local Institution - 0113 | Lecce | |
| Italy | Local Institution - 0120 | Messina | |
| Italy | Local Institution - 0124 | Messina | |
| Italy | Local Institute | Milano | |
| Italy | Local Institution - 0116 | Milano | |
| Italy | Local Institute | Napoli | |
| Italy | Local Institution - 0114 | Napoli | |
| Italy | Local Institute | Pesaro | Pesaro E Urbino |
| Italy | Local Institution - 0115 | Pesaro | |
| Italy | Local Institution - 0121 | Pescara | |
| Italy | Local Institute | Roma | |
| Italy | Local Institution | Roma | |
| Italy | Local Institution - 0109 | Roma | |
| Italy | Local Institution - 0110 | Roma | |
| Italy | Local Institution - 0118 | Roma | |
| Italy | Local Institution - 0122 | San Giovanni Rotondo (FG) | |
| Italy | Local Institute | Terni | |
| Italy | Local Institution - 0107 | Terni | |
| Italy | Local Institute | Torino | |
| Italy | Local Institution - 0112 | Torino | |
| Italy | Local Institute | Vicenza | |
| Italy | Local Institution - 0117 | Vicenza | |
| United Kingdom | Local Institution - 0098 | Harrow | |
| United Kingdom | Local Institute | Leeds | |
| United Kingdom | Local Institution - 0092 | Leeds | |
| United Kingdom | Local Institution | Liverpool | |
| United Kingdom | Local Institution - 0091 | Liverpool | |
| United Kingdom | Local Institution - 0097 | Manchester | |
| United Kingdom | Local Institute | Nottingham | |
| United Kingdom | Local Institution - 0095 | Nottingham | |
| United Kingdom | Local Institute | Stafford | |
| United Kingdom | Local Institution - 0096 | Stafford | |
| United Kingdom | Local Institute | Swansea | |
| United Kingdom | Local Institution - 0093 | Swansea | |
| United Kingdom | Local Institute | Truro | Cornwall |
| United Kingdom | Local Institution - 0094 | Truro | |
| United States | Local Institute | Amarillo | Texas |
| United States | Local Institution - 0029 | Amarillo | Texas |
| United States | Local Institution | Anaheim | California |
| United States | Pacific Cancer Madical Center | Anaheim | California |
| United States | St. Vincent Anderson Regional Hospital | Anderson | Indiana |
| United States | Local Institution | Birmingham | Alabama |
| United States | Local Institution - 0021 | Birmingham | Alabama |
| United States | Florida Cancer Specialists & Research Institute | Brooksville | Florida |
| United States | Local Institution | Brooksville | Florida |
| United States | Local Institution - 0063 | Bryan | Texas |
| United States | East Valley Hematology And Oncology Medical Group | Burbank | California |
| United States | Gabrail Cancer Center Research | Canton | Ohio |
| United States | Local Institute | Canton | Ohio |
| United States | Local Institute | Cary | North Carolina |
| United States | Waverly Hematology Oncology | Cary | North Carolina |
| United States | Charleston Oncology | Charleston | South Carolina |
| United States | Local Institute | Charleston | South Carolina |
| United States | Local Institute | Cleveland | Ohio |
| United States | Local Institution - 0019 | Cleveland | Ohio |
| United States | Local Institution | Corona | California |
| United States | Local Institute | Corpus Christi | Texas |
| United States | Dallas Presbyterian Hospital - Texas Oncology PA | Dallas | Texas |
| United States | Local Institute | Dallas | Texas |
| United States | Local Institute | Dallas | Texas |
| United States | Local Institute | Dallas | Texas |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | Local Institution - 0061 | Des Moines | Iowa |
| United States | Bms Clinical Research Center | Does Not Exist | New Jersey |
| United States | The Oncology Institute Of Hope And Innovation | Downey | California |
| United States | Michael and Dianne Bienes Cancer Center | Fort Lauderdale | Florida |
| United States | Compassionate Cancer Care Medical Group | Fountain Valley | California |
| United States | Texas Oncology-Garland | Garland | Texas |
| United States | Gaston Hematology & Oncology | Gastonia | North Carolina |
| United States | Local Institution | Gastonia | North Carolina |
| United States | Local Institute | Goodyear | Arizona |
| United States | Indiana Blood and Marrow Transplantation LLC | Indianapolis | Indiana |
| United States | Local Institution | Indianapolis | Indiana |
| United States | Local Institution - 0059 | Jackson | Mississippi |
| United States | Local Institution | Jacksonville | Florida |
| United States | Local Institution - 0017 | Jacksonville | Florida |
| United States | Local Institute | Kansas City | Missouri |
| United States | Research Medical Center | Kansas City | Missouri |
| United States | Local Institute | Knoxville | Tennessee |
| United States | University of Tennessee Medical Center | Knoxville | Tennessee |
| United States | Cancer Center of Acadiana at Lafayette General Health | Lafayette | Louisiana |
| United States | Local Institution | Lafayette | Louisiana |
| United States | Local Institution - 0062 | Lexington | Kentucky |
| United States | Local Institution - 0060 | Lincoln | Nebraska |
| United States | Local Institution - 0064 | London | Kentucky |
| United States | Local Institute | Los Angeles | California |
| United States | Local Institute | Louisville | Kentucky |
| United States | Norton Cancer Institute | Louisville | Kentucky |
| United States | Baptist Cancer Center | Memphis | Tennessee |
| United States | Local Institution | Memphis | Tennessee |
| United States | Local Institution | Minneapolis | Minnesota |
| United States | Local Institute | Missoula | Montana |
| United States | Local Institute | Missoula | Montana |
| United States | Montana Cancer Institute Foundation | Missoula | Missouri |
| United States | Local Institution - 0013 | Muscle Shoals | Alabama |
| United States | Local Institute | Omaha | Nebraska |
| United States | Oncology Hematology West, P.C. | Omaha | Nebraska |
| United States | Local Institute | Portland | Oregon |
| United States | Local Institute | Pottstown | Pennsylvania |
| United States | Pottstown Hospital Tower Health - Oncology | Pottstown | Pennsylvania |
| United States | Local Institute | Saint Joseph | Missouri |
| United States | Local Institution | Saint Louis | Missouri |
| United States | Local Institution - 0015 | Saint Louis | Missouri |
| United States | Cancer Care Centers Of South Texas | San Antonio | Texas |
| United States | Local Institute | San Antonio | Texas |
| United States | Local Institute | Santa Rosa | California |
| United States | St Joseph Heritage Healthcare | Santa Rosa | California |
| United States | Summit Cancer Care | Savannah | Georgia |
| United States | Local Institute | Seattle | Washington |
| United States | VA Puget Sound Health Care System | Seattle | Washington |
| United States | Local Institute | Sherman | Texas |
| United States | Local Institution - 0028 | Sherman | Texas |
| United States | Local Institution | Shreveport | Louisiana |
| United States | Local Institution - 0009 | Shreveport | Louisiana |
| United States | Local Institute | Sioux City | Iowa |
| United States | Local Institution - 0018 | Sioux City | Iowa |
| United States | Local Institution | Skokie | Illinois |
| United States | Local Institute | Southaven | Mississippi |
| United States | Cancer Care Northwest | Spokane | Washington |
| United States | Local Institute | Spokane | Washington |
| United States | Local Institution | Springfield | Missouri |
| United States | Mercy Medical Research Institute | Springfield | Missouri |
| United States | SIU Simmons Cancer Institute | Springfield | Illinois |
| United States | Stony Brook University Hospital | Stony Brook | New York |
| United States | Local Institute | Tulsa | Oklahoma |
| United States | Tulsa Cancer Institute PLLC | Tulsa | Oklahoma |
| United States | Local Institution - 0012 | Urbana | Illinois |
| United States | Local Institute | Valdosta | Georgia |
| United States | Pearlman Cancer Center | Valdosta | Georgia |
| United States | Local Institution - 0057 | Washington | District of Columbia |
| United States | Minnesota Oncology Hematology, P.A. | Woodbury | Minnesota |
| United States | Local Institute | Yakima | Washington |
| United States | Local Institute | Yakima | Washington |
| United States | Yakima Valley Memorial Hospital | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Canada, France, Germany, Italy, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM) | Up to 5 years | ||
| Primary | Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM) | Up to 8 years | ||
| Primary | Progression-Free Survival (PFS) for participants with RRMM | Up to 5 years | ||
| Primary | Progression-Free Survival (PFS) for participants with NDMM | Up to 8 years | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Healthcare resource utilization (HCRU) for participants with RRMM | Up to 5 years | ||
| Secondary | Healthcare resource utilization (HCRU) for participants with NDMM | Up to 8 years | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Incidence of Adverse Events (AEs) for participants with RRMM | Up to 5 years | ||
| Secondary | Incidence of Adverse Events (AEs) for participants with NDMM | Up to 8 years |
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