PRospective Multiple Myeloma Impact Study (PROMMIS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02911571|
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : June 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Device: MMprofiler SKY92 gene signature||Not Applicable|
This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in MM patients.
Eligible patients will have their tumor sample analyzed for the prognostic MMprofiler SKY92, several cytogenetic markers, gene expression markers, and gene expression clusters.
A total of 250 patients will be enrolled from up to 9 US centers. Patients will be followed 5 years after diagnosis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Multicenter Study to Measure the Impact of MMprofiler on Treatment Intention in Active Multiple Myeloma Patients|
|Actual Study Start Date :||February 27, 2018|
|Estimated Primary Completion Date :||June 15, 2020|
|Estimated Study Completion Date :||December 1, 2024|
Experimental: MMprofiler SKY92
Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature
Device: MMprofiler SKY92 gene signature
MMprofiler is a gene expression assay system for detection of the presence (or absence) of the SKY92 "high-risk" gene signature to aid in the determination of the Multiple Myeloma patient's prognosis
- Change in treatment intention [ Time Frame: Treatment intention is measured before MMprofiler SKY92 and within 4 weeks after MMprofiler ]Change in treatment intention will be assessed with a physician questionnaire pre- and post MMprofiler assessment
- 3 year Progression Free Survival [ Time Frame: 3 years after diagnosis ]Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
- 3 year Overall Survival [ Time Frame: 3 years after diagnosis ]Duration from start of the treatment to death (regardless of cause of death).
- 5 year Progression Free Survival [ Time Frame: 5 years after diagnosis ]Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
- 5 year Overall Survival [ Time Frame: 5 years after diagnosis ]Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
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): NCT02911571
|Contact: Lisette Stork, MScfirstname.lastname@example.org|
|Contact: Femke de Snoo, MD, PhDemail@example.com|
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: David Vesole, MD|
|United States, Georgia|
|Winship Cancer Institute, Emory University||Not yet recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Ajay Nooka, MD|
|United States, New Jersey|
|Hackensack University Medical Center||Recruiting|
|Hackensack, New Jersey, United States, 07601|
|Contact: David Siegel, MD|
|Principal Investigator: David Siegel, MD|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Suzanne Lentzsch, MD|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|Contact: Ruben Niesvizky, MD|
|United States, North Carolina|
|Levine Cancer Institute||Recruiting|
|Charlotte, North Carolina, United States, 28204|
|Contact: Saad Usmani, MD|
|Wake Forest Baptist Medical Center,||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Cesar Rodriguez, MD|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Parameswaran Hari, MD|
|Principal Investigator:||Saad Usmani, MD||Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System|