Daratumumab for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Multiple Myeloma+1 More
Daratumumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug combo to see if it's safe and effective in treating people with myeloma.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: 12 Months

12 Months
Best Stringent Complete Response
Duration of Response (DOR)
Incidence of Adverse Events
Incidence of Treatment-Emergent Adverse Events
Minimal Residual Disease Evaluation
Objective Response Rate (Cohort A)
Objective Response Rate (Cohort B)
Overall Survival (OS)
Progression-Free Survival (PFS)
Time To Progression (TTP)
Time on Study (TOS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

KdD - Carfilzomib, Dexamethasone and Daratumumab
37%Thrombocytopenia
33%Anaemia
31%Diarrhoea
30%Hypertension
29%Upper respiratory tract infection
24%Fatigue
19%Dyspnoea
18%Nausea
18%Insomnia
17%Pyrexia
17%Cough
16%Back pain
16%Bronchitis
14%Neutropenia
13%Headache
12%Vomiting
12%Pneumonia
12%Muscle spasms
11%Oedema peripheral
9%Hyperglycaemia
9%Decreased appetite
9%Respiratory tract infection
9%Lymphopenia
9%Asthenia
9%Nasopharyngitis
8%Neuropathy peripheral
8%Arthralgia
7%Infusion related reaction
7%Constipation
7%Influenza
7%Dizziness
7%Productive cough
6%Peripheral sensory neuropathy
6%Leukopenia
6%Chills
6%Hypokalaemia
6%Pain in extremity
6%Rash
5%Urinary tract infection
5%Conjunctivitis
4%Sepsis
4%Oedema
2%Atrial fibrillation
2%Lower respiratory tract infection
2%Septic shock
2%Acute kidney injury
2%Plasma cell myeloma
2%Pulmonary embolism
2%Pulmonary oedema
1%Plasmacytoma
1%Osteonecrosis of jaw
1%Syncope
1%Sudden death
1%Blood creatinine increased
1%Pulmonary hypertension
1%Respiratory failure
1%Febrile neutropenia
1%Thrombotic thrombocytopenic purpura
1%Cardiac failure acute
1%Cardiac failure
1%Myocardial ischaemia
1%Atrial flutter
1%Cataract
1%Bacteraemia
1%Upper gastrointestinal haemorrhage
1%Hepatic function abnormal
1%Lung infection
1%Device related infection
1%Respiratory syncytial virus infection
1%Tumour lysis syndrome
1%Viral infection
1%Overdose
1%Posterior reversible encephalopathy syndrome
1%Interstitial lung disease
1%Pleural effusion
1%Pneumonitis
1%Cardiac arrest
1%Acute myocardial infarction
1%Cerebrovascular accident
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%.

Trial Design

2 Treatment Groups

Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
1 of 2
Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)
1 of 2
Experimental Treatment

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tretinoin
FDA approved
Pomalidomide
FDA approved
Dexamethasone
FDA approved
Daratumumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
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

Eligibility Criteria

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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 2022

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.

References