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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

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.

Condition or disease
Multiple Myeloma

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.


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Study Type : Observational
Estimated Enrollment : 1700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
Study Start Date : June 13, 2012
Estimated Primary Completion Date : June 13, 2024
Estimated Study Completion Date : June 13, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort
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.




Primary Outcome Measures :
  1. 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

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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838512


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

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Sponsors and Collaborators
Bristol-Myers Squibb
AbbVie
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01838512     History of Changes
Other Study ID Numbers: CA204-008
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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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