This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03158688) in the KdD - Carfilzomib, Dexamethasone and Daratumumab ARM group. Side effects include: Thrombocytopenia with 37%, Anaemia with 33%, Diarrhoea with 31%, Hypertension with 30%, Upper respiratory tract infection with 29%.
2 Treatment Groups
Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
1 of 2
Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)
1 of 2
43 Total Participants · 2 Treatment Groups
Primary Treatment: Daratumumab · No Placebo Group · Phase 2
Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)Experimental Group · 4 Interventions: All-trans retinoic acid, Pomalidomide, Dexamethasone, Daratumumab · Intervention Types: Drug, Drug, Drug, Drug
Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)Experimental Group · 4 Interventions: All-trans retinoic acid, Pomalidomide, Dexamethasone, Daratumumab · Intervention Types: Drug, Drug, Drug, Drug
Drug Approval Stage
How many patients have taken this drug
Screening: ~3 weeks
Reporting: 12 months
Who is running the clinical trial?
Janssen, LPIndustry Sponsor
144 Previous Clinical Trials
200,284 Total Patients Enrolled
20 Trials studying Multiple Myeloma
3,278 Patients Enrolled for Multiple Myeloma
Hackensack Meridian HealthLead Sponsor
110 Previous Clinical Trials
23,554 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,432 Patients Enrolled for Multiple Myeloma
Noa Biran, MDPrincipal InvestigatorHackensack Meridian Health
3 Previous Clinical Trials
226 Total Patients Enrolled
3 Trials studying Multiple Myeloma
226 Patients Enrolled for Multiple Myeloma
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:
For cohort B, patients must have been exposed to Dara + Pom + Dex and must have had a positive response ( tumor shrinkage, no new tumor growth, or stable disease) to this combination.
urine monoclonal protein excretion (UMPE)
A protein found in the urine that is present in large amounts and is not normally there.
If serum FLC ratio is abnormal and serum immunoglobulin free light chain (FLC) ≥10 mg/dL (100 mg/L), then this is a strong indicator of disease.
The life expectancy for this patient is more than three months.
For cohort A, patients must have been previously exposed to Dara+Len+Dex and must have at least achieved stable disease to this combination.
or Serum M-protein ≥1.0 g/dL
The patient has been diagnosed with a new plasma cell tumor, either through a biopsy or imaging
Eligible participants must have received their last dose of Daratumumab no more than 3 months before the first day of study treatment.
serum IgA ≥1 g/dL
The person has a serum monoclonal protein level of at least 0.5 g/dL and a serum IgA level of at least 1 g/dL.
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.