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

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ClinicalTrials.gov Identifier: NCT01838512
Recruitment Status : Recruiting
First Posted : April 24, 2013
Last Update Posted : September 27, 2018
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date April 19, 2013
First Posted Date April 24, 2013
Last Update Posted Date September 27, 2018
Study Start Date June 13, 2012
Estimated Primary Completion Date June 13, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2013)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01838512 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 23, 2013)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
Official Title Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
Brief Summary 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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Multiple Myeloma
Intervention Not Provided
Study 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.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 2, 2017)
1700
Original Estimated Enrollment
 (submitted: April 23, 2013)
1000
Estimated Study Completion Date June 13, 2024
Estimated Primary Completion Date June 13, 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Michelle Grossman, BS 781 269 5276 Michelle.Grossman@parexel.com
Contact: Alison Huff, BS 905.425.1248 Alison.Huff@parexel.com
Listed Location Countries Canada,   France,   Germany,   Italy,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01838512
Other Study ID Numbers CA204-008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor Bristol-Myers Squibb
Collaborators AbbVie
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2018