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Monoclonal Antibodies
Blood for research assessments for Multiple Myeloma
Phase 2
Waitlist Available
Led By Mark A Schroeder, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years following initiation of treatment (estimated to 3 years and 8 months)
Awards & highlights
Summary
This trial is studying whether increasing the frequency of the drug daratumumab, for people with myeloma who have had a good initial response to the drug but then experienced biochemical progression, can recapture the initial response and delay clinical progression or the need for other treatment changes.
Eligible Conditions
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years following initiation of treatment (estimated to 3 years and 8 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years following initiation of treatment (estimated to 3 years and 8 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
Duration of response (DOR)
Heart rate
Overall survival
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Dara-SC Re-EscalationExperimental Treatment3 Interventions
-Re-escalation will include weekly dosing for two 4-week cycles (8 doses, Days 1, 8, 15, and 22 of each 28-day cycle) followed by dosing every-other-week thereafter (Days 1 and 15 of each 28-day cycle). Patients will remain on study treatment until meeting clinical progression.
Group II: Arm 2: Dara-SCActive Control3 Interventions
-Continued subcutaneous daratumumab and and hyaluronidase-fihj (1,800mg/30,000U, \[Dara-SC\])
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,970 Previous Clinical Trials
2,308,623 Total Patients Enrolled
34 Trials studying Multiple Myeloma
2,297 Patients Enrolled for Multiple Myeloma
Janssen, LPIndustry Sponsor
166 Previous Clinical Trials
308,807 Total Patients Enrolled
25 Trials studying Multiple Myeloma
9,662 Patients Enrolled for Multiple Myeloma
Mark A Schroeder, M.D.Principal InvestigatorWashington University School of Medicine
4 Previous Clinical Trials
154 Total Patients Enrolled
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