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|
INCLUSION. 1. Participants ≥18 years of age or legal age of consent per local regulations (whichever is greater). 2. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. 3. ECOG status (Appendix A) of ≤2 and able to tolerate all applicable treatments per investigator's evaluation and standard institutional criteria. 4. Both transplant eligible and ineligible myeloma patients can be included in this study. If applicable, participant should be able to tolerate all treatments per investigator's evaluation, including high-dose chemotherapy and autologous stem cell transplant (ASCT) based on standard criteria at the institution where this treatment will be administered. 5. Participant must have a diagnosis of active MM according to International Myeloma Working Group (IMWG) diagnostic criteria. 6. Participant must also have measurable disease per protocol. 7. Participant agrees to refrain from blood donations during therapy on study and for 12 weeks after therapy is completed. 8. Participant must be registered in and must comply with all requirements of REMSTM program for lenalidomide. 9. Female participant who:
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 Michigan Rogel Cancer Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Jing Christine Ye, M.D.|
|Principal Investigator Affiliation||University of Michigan|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Dara-Rd followed by Dara-RVd
Induction regimen with Daratumumab, Lenalidomide and Dexamethasone (Dara-Rd) in all study subjects, weeks 1-24 Consolidation regimen with Daratumumab, Lenalidomide, Bortezomib and Dexamethasone (Dara-RVd) in post-induction MRD+ population, weeks 25-36 Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88 Maintenance regimen with lenalidomide (R) until progression or intolerance
Drug: - Daratumumab
Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses). Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88)
Drug: - Lenalidomide
Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24) Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36) Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression
Drug: - Bortezomib
Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36)
Drug: - Dexamethasone
Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.