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Active, not recruiting

NCT Number: NCT01838512

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institute, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM)

    Time frame: Up to 5 years

  2. Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM)

    Time frame: Up to 8 years

  3. Progression-Free Survival (PFS) for participants with RRMM

    Time frame: Up to 5 years

  4. Progression-Free Survival (PFS) for participants with NDMM

    Time frame: Up to 8 years

Secondary outcomes

  1. Treatment patterns of approved MM therapies as measured by the Response Rate for participants with RRMM

    Time frame: From study index date until the enrollment date, assessed up to 5 years

  2. Treatment patterns of approved MM therapies as measured by the Response Rate for participants with NDMM

    Time frame: From study index date until the enrollment date, assessed up to 8 years

  3. Healthcare resource utilization (HCRU) for participants with RRMM

    Time frame: Up to 5 years

  4. Healthcare resource utilization (HCRU) for participants with NDMM

    Time frame: Up to 8 years

  5. Healthcare resource utilization (HCRU) for participants with RRMM

    Time frame: 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

  6. Healthcare resource utilization (HCRU) for participants with NDMM

    Time frame: 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

  7. Patient reported outcomes as measured by EQ-5D summary index for participants with RRMM

    Time frame: From start of initial therapy to questionnaire completion, assessed up to 5 years

  8. Patient reported outcomes as measured by EQ-5D summary index for participants with NDMM

    Time frame: From start of initial therapy to questionnaire completion, assessed up to 8 years

  9. Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with RRMM

    Time frame: From start of initial therapy to questionnaire completion, assessed up to 5 years

  10. Patient reported outcomes as measured by EORTC-QLQ-C30 for participants with NDMM

    Time frame: From start of initial therapy to questionnaire completion, assessed up to 8 years

  11. Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with RRMM

    Time frame: From start of initial therapy to questionnaire completion, assessed up to 5 years

  12. Patient reported outcomes as measured by EORTC-QLQ-MY20 for participants with NDMM

    Time frame: From start of initial therapy to questionnaire completion, assessed up to 8 years

  13. Incidence of Adverse Events (AEs) for participants with RRMM

    Time frame: Up to 5 years

  14. Incidence of Adverse Events (AEs) for participants with NDMM

    Time frame: Up to 8 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2012
Primary completion
2030
Study completion
2030
First posted
Apr 24, 2013
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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