Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. 12. Patients must be willing to take appropriate DVT prophylaxis, either aspirin, low molecular weight heparin, direct oral anticoagulants, or warfarin while receiving lenalidomide.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Illinois at Chicago|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
This is a phase II study where patients will undergo isatuximab and lenalidomide maintenance starting at day 90 (+/-30 days) after Autologous Stem Cell Transplant (ASCT) provided they have achieved at least Partial Response (PR).Patients may have received any number of cycles of induction therapy prior to stem cell transplant. Patients will be enrolled prior to ASCT or up to day +90 (+/-30 days) disease reassessment. Patients will undergo disease reassessment per standard of care including Bone Marrow (BM) examination and Minimal Residual Disease (MRD) testing by Next Generation Sequencing (NGS) MRD testing is required at day 90 for patients in Complete Response (CR). In addition, NGS testing must be performed for those patients not in CR who have not previously had initial sample testing for identification of B cell clonality. If patients have failed to achieve CR and have prior baseline testing for B cell clonality, MRD monitoring can be omitted at 90 days as patients will be assumed to be MRD-positive. All patients who fail to achieve MRD-negative CR (at a resolution of 10-5) patients will begin treatment with isatuximab and lenalidomide by day 180 (i.e. all patients in PR, Very Good Partial Response (VGPR) or MRD-positive CR). Patients will be monitored for disease response and have BM testing every 12 months to evaluate for the presence of MRD for a total of 3 years, or until disease progression or unacceptable toxicity. If patients experience progression or relapse at any time, BM testing will be performed.
Experimental: Isatuximab and Lenalidomide Maintenance
All participants will receive: Isatuximab 10mg/kg IV Days 1,8, 15, 22 Cycle 1 (all cycles 28 days). Isatuximab 10mg/kg Days 1, 15 Cylces 2 and 3. Isatuximab 10mg/kg Day 1, Cylces 4-39. Lenalidomide 10mg PO Days 1-28 Cylces 1-3 (all cycles 28 days) Lenalidomide 15mg PO Days 1-28 Cycle 4 and can continue until disease progression.
Drug: - Isatuximab
Isatuximab 10mg/kg IV Days 1,8, 15, 22 Cycle 1 (all cycles 28 days). Isatuximab 10mg/kg Days 1, 15 Cylces 2 and 3. Isatuximab 10mg/kg Day 1, Cylces 4-39.
Drug: - Lenalidomide
Lenalidomide 15mg PO Days 1-28 Cycle 4 and can continue until disease progression.