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Trial record 1 of 5 for:    preamble
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Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE) (PREAMBLE)

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01838512
First received: April 19, 2013
Last updated: March 2, 2017
Last verified: March 2017
  Purpose
This is a non-interventional observational study aimed at understanding the real world effectiveness of novel agents used in treating multiple myeloma and their impact on patient-reported outcomes. This study will collect information that is already in medical records regarding treatment and diagnostic procedures. Patients are asked to complete questionnaires for patient-reported outcome measures.

Condition
Multiple Myeloma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Clinical effectiveness of IMiDs, proteasome inhibitors, and combination novel therapies (an IMiD plus a proteasome inhibitor) in relapsed/refractory MM in real-world clinical practice. [ Time Frame: Up to 6 years ]
    Clinical effectiveness: defined as PFS, response rates, and OS

  • Examine PFS as a potential predictor of OS [ Time Frame: Up to 6 years ]

Secondary Outcome Measures:
  • Healthcare resource utilization and associated costs [ Time Frame: Up to 6 years ]
  • Patient reported outcomes (health-related QoL and work productivity and activity) [ Time Frame: Up to 6 years ]
  • Occurrence of secondary malignancies and AEs [ Time Frame: Up to 6 years ]

Estimated Enrollment: 1700
Study Start Date: June 2012
Estimated Study Completion Date: June 2024
Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts
IMiDs

Diagnosed relapsed/refractory multiple myeloma patients who receive IMiD treatment

Note: Additional use of corticosteroids and/or cytotoxic agents (eg, alkylating agents) is permitted for all 3 cohorts.

Proteasome inhibitors

Diagnosed relapsed/refractory multiple myeloma patients who receive Proteasome inhibitor treatment

Note: Additional use of corticosteroids and/or cytotoxic agents (eg, alkylating agents) is permitted for all 3 cohorts.

Combination novel therapies

Diagnosed relapsed/refractory multiple myeloma patients who received combinations novel therapies (an IMiD plus a proteasome inhibitor) treatment

Note: Additional use of corticosteroids and/or cytotoxic agents (eg, alkylating agents) is permitted for all 3 cohorts.


Detailed Description:

This is a prospective, multi-regional, observational cohort study with up to 3 years of follow up per patient. During the entire observational period (from the first patient first visit to the last patient last visit), vital status will be collected every 6 months on all patients, including those who complete the 3-year follow up prior to study conclusion. The study will include 3 cohorts of patients receiving one of the following classes of treatments for MM:

  • IMiDs
  • Proteasome inhibitors
  • Combination novel therapies (an IMiD plus a proteasome inhibitor)

    • Additional use of corticosteroids and/or cytotoxic agents (eg, alkylating agents) is permitted for all 3 cohorts.

Medicines that are prescribed in a manner that is consistent with the terms of the approved marketing authorization or in line with the current standard of practice of the participating physician will be allowed.

Note : Treatment with the current regimen:

i. must have been initiated within 90 days before consent for this study OR ii. 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.

Enrollment of approximately 1000 patients will occur during an approximate 36-month timeframe, and each patient will be followed for up to 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with relapsed or refractory Multiple Myeloma(MM) initiating a new line of therapy that contains an immunomodulatory drugs (IMiDs), an proteasome inhibitors (PIs), or both.
Criteria

Inclusion Criteria:

  • Patients diagnosed with relapsed or refractory MM who have received at least one prior line of therapy for MM
  • Age of 18 years (or legal age of consent) or older at time of entry into the study
  • Have documented progression from a prior line of therapy
  • Patients 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:

IMiD* Proteasome inhibitor* Combination novel therapies (an IMiD plus a proteasome inhibitor)*

Exclusion Criteria:

  • Patients who are currently participating in a clinical trial for MM
  • Patients who are not willing or able to provide informed consent
  • Patients who are incarcerated
  • Patients under compulsory detention for treatment of a physical (eg, infectious) or psychiatric illness Patients who are currently receiving treatment for primary cancer other than multiple myeloma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838512

Contacts
Contact: Michelle Grossman, BS 781 269 5276 Michelle.Grossman@parexel.com
Contact: Alison Huff, BS 905.425.1248 Alison.Huff@parexel.com

  Hide Study Locations
Locations
United States, Alabama
Local Institution Recruiting
Birmingham, Alabama, United States, 35213
United States, Arizona
Local Institute Recruiting
Goodyear, Arizona, United States, 85338
United States, California
Local Institution Recruiting
Anaheim, California, United States, 92801
Local Institution Recruiting
Corona, California, United States, 92880
Local Institute Recruiting
Los Angeles, California, United States, 90013
Local Institute Recruiting
Santa Rosa, California, United States, 95403
United States, Florida
Local Institution Recruiting
Brooksville, Florida, United States, 34613
Local Institution Recruiting
Jacksonville, Florida, United States, 32256
United States, Georgia
Local Institute Recruiting
Valdosta, Georgia, United States, 31602
United States, Illinois
Local Institution Recruiting
Skokie, Illinois, United States, 60077
United States, Indiana
Local Institution Recruiting
Indianapolis, Indiana, United States, 46237
United States, Iowa
Local Institute Recruiting
Sioux City, Iowa, United States, 51101
United States, Kentucky
Local Institute Recruiting
Louisville, Kentucky, United States, 40201
United States, Louisiana
Local Institution Recruiting
Lafayette, Louisiana, United States, 70503
Local Institution Recruiting
Shreveport, Louisiana, United States, 71103
United States, Minnesota
Local Institution Recruiting
Minneapolis, Minnesota, United States, 55404
United States, Mississippi
Local Institute Recruiting
Southaven, Mississippi, United States, 38671
United States, Missouri
Local Institute Recruiting
Kansas City, Missouri, United States, 64132
Local Institute Recruiting
Saint Joseph, Missouri, United States, 64501
Local Institution Recruiting
Saint Louis, Missouri, United States, 63110
Local Institution Recruiting
Springfield, Missouri, United States, 65804
United States, Montana
Local Institute Recruiting
Missoula, Montana, United States, 59802
Local Institute Recruiting
Missoula, Montana, United States, 59807
United States, Nebraska
Local Institute Recruiting
Omaha, Nebraska, United States, 68124
United States, North Carolina
Local Institute Recruiting
Cary, North Carolina, United States, 27518
Local Institution Recruiting
Gastonia, North Carolina, United States, 28054
United States, Ohio
Local Institute Recruiting
Canton, Ohio, United States, 44718
Local Institute Recruiting
Cleveland, Ohio, United States, 44109-1900
United States, Oklahoma
Local Institute Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Local Institute Recruiting
Portland, Oregon, United States, 97200
United States, Pennsylvania
Local Institute Recruiting
Pottstown, Pennsylvania, United States, 19464
United States, South Carolina
Local Institute Recruiting
Charleston, South Carolina, United States, 29414
United States, Tennessee
Local Institute Recruiting
Knoxville, Tennessee, United States, 37920
Local Institution Recruiting
Memphis, Tennessee, United States, 38120
United States, Texas
Local Institute Recruiting
Amarillo, Texas, United States, 79106
Local Institute Recruiting
Corpus Christi, Texas, United States, 78350
Local Institute Recruiting
Dallas, Texas, United States, 75229
Local Institute Recruiting
Dallas, Texas, United States, 75231
Local Institute Recruiting
Dallas, Texas, United States, 75390
Local Institute Recruiting
San Antonio, Texas, United States, 78217
Local Institute Recruiting
Sherman, Texas, United States, 75090
United States, Washington
Local Institute Recruiting
Seattle, Washington, United States, 98101
Local Institute Recruiting
Spokane, Washington, United States, 99202
Local Institute Recruiting
Yakima, Washington, United States, 98901
Local Institute Recruiting
Yakima, Washington, United States, 98902
Canada, Ontario
Local Institute Recruiting
Toronto, Ontario, Canada, M4N 3M5
Local Institute Recruiting
Weston, Ontario, Canada, M9N 1N8
France
Local Institute Recruiting
Blois, France
Local Institute Recruiting
Chalon sur Saone, France
Local Institute Recruiting
La Roche sur Yon, France
Local Institute Recruiting
Limoges, France
Local Institute Recruiting
Meaux, France
Local Institute Recruiting
Nantes, France
Local Institute Recruiting
Rennes, France, 35033
Germany
Local Institute Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Local Institute Recruiting
Hamm, Nordrhein-Westfalen, Germany, 59071
Local Institute Recruiting
Aschaffenburg, Germany, 63739
Local Institute Recruiting
Berlin, Germany, 10407
Local Institute Recruiting
Dresden, Germany, 01099
Local Institute Recruiting
Magdeburg, Germany, 39104
Local Institute Recruiting
München, Germany
Local Institute Recruiting
Rostock, Germany
Italy
Local Institute Recruiting
Pesaro, Pesaro e Urbino, Italy, 61122
Local Institute Recruiting
Ancona, Italy, 042002
Local Institute Recruiting
Ancona, Italy, 60126
Local Institute Recruiting
Cagliari, Italy, B354
Local Institute Recruiting
Firenze, Italy, 50139
Local Institute Recruiting
Lecce, Italy, 73100
Local Institute Recruiting
Milano, Italy, 20121
Local Institute Recruiting
Napoli, Italy, 80136
Local Institute Recruiting
Roma, Italy, 00161
Local Institution Recruiting
Roma, Italy, 00189
Local Institute Recruiting
Terni, Italy, 5100
Local Institute Recruiting
Torino, Italy, 10126
Local Institute Recruiting
Vicenza, Italy, 36100
United Kingdom
Local Institute Recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
Local Institute Recruiting
Leeds, United Kingdom, LS9 7TF
Local Institution Recruiting
Liverpool, United Kingdom, L7 8XP
Local Institute Recruiting
Nottingham, United Kingdom, NG5 1PB
Local Institute Recruiting
Stafford, United Kingdom, ST16 3SA
Local Institute Recruiting
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01838512     History of Changes
Other Study ID Numbers: CA204-008
Study First Received: April 19, 2013
Last Updated: March 2, 2017

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Proteasome Inhibitors
Alkylating Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 19, 2017