Clinical Trials in Egypt / NCT01838512
Active, not recruiting
Observational
Prospective Research Assessment in Multiple Myeloma: An Observational Evaluation (PREAMBLE)
NCT01838512 · tracked via the Priya Life Science Egypt tracker
Condition(s) studied
Multiple Myeloma
Study 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.
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
Primary outcome measure(s)
- Overall Survival (OS) for participants with relapsed/refractory multiple myeloma (RRMM) — Up to 5 years
- Overall Survival (OS) for participants with newly-diagnosed multiple myeloma (NDMM) — Up to 8 years
- Progression-Free Survival (PFS) for participants with RRMM — Up to 5 years
- Progression-Free Survival (PFS) for participants with NDMM — Up to 8 years
Trial sites (130)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution | Birmingham | Alabama | |
| Local Institute | Goodyear | Arizona | |
| Local Institution - 0023 | Anaheim | California | |
| Local Institution | Anaheim | California | |
| Local Institution - 0045 | Burbank | California | |
| Local Institution | Corona | California | |
| Local Institution - 0048 | Downey | California | |
| Local Institution - 0052 | Fountain Valley | California | |
| Local Institute | Los Angeles | California | |
| Local Institute | Santa Rosa | California | |
| Local Institution - 0051 | Santa Rosa | California | |
| Local Institution | Brooksville | Florida | |
| Local Institution - 0044 | Fort Lauderdale | Florida | |
| Local Institution | Jacksonville | Florida | |
| Local Institute | Valdosta | Georgia | |
| Local Institution - 0047 | Valdosta | Georgia | |
| Local Institution | Skokie | Illinois | |
| Local Institution - 0041 | Springfield | Illinois | |
| Local Institution - 0058 | Anderson | Indiana | |
| Local Institution - 0011 | Indianapolis | Indiana | |
| Local Institution | Indianapolis | Indiana | |
| Local Institute | Sioux City | Iowa | |
| Local Institute | Louisville | Kentucky | |
| Local Institution - 0042 | Louisville | Kentucky | |
| Local Institution | Lafayette | Louisiana | |
| Local Institution | Shreveport | Louisiana | |
| Local Institution | Minneapolis | Minnesota | |
| Local Institution - 0030 | Woodbury | Minnesota | |
| Local Institute | Southaven | Mississippi | |
| Local Institute | Kansas City | Missouri | |
| Local Institution - 0050 | Kansas City | Missouri | |
| Local Institution - 0037 | Missoula | Missouri | |
| Local Institute | Saint Joseph | Missouri | |
| Local Institution - 0020 | Springfield | Missouri | |
| Local Institution | Springfield | Missouri | |
| Local Institution | St Louis | Missouri | |
| Local Institute | Missoula | Montana | |
| Local Institute | Missoula | Montana | |
| Local Institute | Omaha | Nebraska | |
| Local Institution - 0024 | Omaha | Nebraska |
+ 90 more sites — see the full list on the official registry below.
Other trials for the same condition
P-BCMA-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Multiple Myeloma
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT01838512 on ClinicalTrials.gov ↗ ← All trials in Egypt