Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
18 Years and older, Male and Female
Summary
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.
Objectives
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
- 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 Sites in Georgia
2501 North Patterson Street
Valdosta, GA 31602
229-259-4628
www.sgmc.org
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.