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Trial ID CA204-008  |   NCT01838512

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

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Summary

  • Male and Female Gender icon
  • 18+
    Age Range
  • 13
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

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Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria

Inclusion Criteria Icon img
: For RRMM participants who have received at least one prior line of therapy (LoT) for MM:
  • Have documented progression from a prior LoT
    1. 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:
      1. IMiDs
        1. PIs
          1. Combination of IMiD + PI
            1. 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:
              1. Eligible to receive frontline therapy for MM (no prior MM treatment)
                1. 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:
                  1. IMiDs
                    1. PIs
                      1. Combination of IMiD + PI
                        1. Newer agents with novel MOAs alone or in combination (eg, mAbs, HDACIs, Akt inhibitors, SINE, or CAR T-cell therapies)

                          Exclusion Criteria

                          Exclusion Criteria Icon
                          :
                          • Participants who are currently participating in a clinical trial for MM
                            1. Participants who are currently receiving treatment for primary cancer other than MM
                              1. Participants who are not willing or able to provide informed consent
                                1. Participants who are incarcerated
                                  1. Participants under compulsory detention for treatment of a physical (eg, infectious) or psychiatric illness Other protocol-defined inclusion/exclusion criteria apply
                                    Additional Information *

                                    Treatment Options

                                    Study Arms

                                    ASSIGNED INTERVENTION

                                    Study Arms

                                    Cohort 1

                                    ASSIGNED INTERVENTION

                                    Study Arms

                                    Cohort 2

                                    ASSIGNED INTERVENTION
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