DARA RVD For High Risk SMM (PRISM)
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ClinicalTrials.gov Identifier: NCT04775550 |
Recruitment Status :
Recruiting
First Posted : March 1, 2021
Last Update Posted : September 21, 2023
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | February 25, 2021 | ||||||||||||||
First Posted Date ICMJE | March 1, 2021 | ||||||||||||||
Last Update Posted Date | September 21, 2023 | ||||||||||||||
Actual Study Start Date ICMJE | March 8, 2021 | ||||||||||||||
Estimated Primary Completion Date | March 8, 2026 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
Proportion of high risk smoldering multiple myeloma (SMM) patients who are MRD negative (MRD-) [ Time Frame: 2 years ] MRD negative disease (MRD-) is defined as zero residual sequence cells detected at a level of one million cells. At time of final analysis, the 2-year MRD- rate will be summarized as a proportion with a 90% exact binomial confidence interval
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||
Change History | |||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | DARA RVD For High Risk SMM | ||||||||||||||
Official Title ICMJE | B- PRISM (Precision Intervention Smoldering Myeloma): A Phase II Trial of Combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in High- Risk Smoldering Multiple Myeloma | ||||||||||||||
Brief Summary | The purpose of this research study is to learn whether the combination of daratumumab SC ( Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma. The names of the study drugs involved in this study are:
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Detailed Description | The purpose of this research study is to learn whether the combination of daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone works in treating smoldering multiple myeloma and preventing progression to active or symptomatic multiple myeloma. This combination of drugs are considered "investigational" which means it has not been approved in this combination for smoldering myeloma by the United States Food and Drug Administration. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits The names of the study drugs involved in this study are:
Participants may be treated for up to 24 months and will be followed for up to 3 years. It is expected that about 30 people will take part in this research study. This research study is a Phase II clinical trial, which tests the effectiveness of an investigational drug(s). The investigational drugs used in this research study are daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone. "Investigational" means that the FDA (the U.S. Food and Drug Administration) has not approved the combination of daratumumab (Darzalex Faspro), lenalidomide (Revlimid), bortezomib (Velcade) and dexamethasone as a treatment regimen for the specific disease. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Daratumumab, Bortezomib,Lenalidomide,Dexamethasone
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Cycle Length is 28 days. The names of the study drugs involved in this study are:
Interventions:
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
60 | ||||||||||||||
Original Estimated Enrollment ICMJE |
30 | ||||||||||||||
Estimated Study Completion Date ICMJE | March 8, 2029 | ||||||||||||||
Estimated Primary Completion Date | March 8, 2026 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||
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Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT04775550 | ||||||||||||||
Other Study ID Numbers ICMJE | 21-007 | ||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Omar Nadeem, MD, Dana-Farber Cancer Institute | ||||||||||||||
Original Responsible Party | Omar Nadeem, Dana-Farber Cancer Institute, Sponsor Investigator | ||||||||||||||
Current Study Sponsor ICMJE | Omar Nadeem, MD | ||||||||||||||
Original Study Sponsor ICMJE | Omar Nadeem | ||||||||||||||
Collaborators ICMJE | Janssen, LP | ||||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||||
Verification Date | September 2023 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |