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Daratumumab for Multiple Myeloma

Emory University Hospital/Winship Cancer Institute, Atlanta, GA
Multiple MyelomaDaratumumab - Biological
Eligibility
18+
All Sexes
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Study Summary

This trial is testing daratumumab, ixazomib, dexamethasone, and bortezomib as a possible treatment for newly diagnosed multiple myeloma.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Up to 5 years after study start

Day 84
Stem cell mobilization
Day 224
≥ Very good partial response (VGPR) response rate
Year 5
Best response on study
Duration of response (DOR)
Minimal residual disease (MRD)
Objective response rate (ORR)
Progression-Free Survival (PFS)
Time to response

Trial Safety

Phase-Based Safety

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

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Side Effects for

KdD - Carfilzomib, Dexamethasone and Daratumumab
39%Thrombocytopenia
37%Hypertension
37%Anaemia
36%Diarrhoea
34%Upper respiratory tract infection
26%Fatigue
22%Dyspnoea
21%Insomnia
20%Back pain
20%Nausea
19%Pyrexia
18%Bronchitis
18%Cough
17%Vomiting
17%Pneumonia
16%Neutropenia
15%Headache
13%Muscle spasms
12%Oedema peripheral
11%Neuropathy peripheral
11%Respiratory tract infection
11%Arthralgia
11%Asthenia
11%Nasopharyngitis
9%Cataract
9%Decreased appetite
9%Hyperglycaemia
9%Lymphopenia
8%Peripheral sensory neuropathy
8%Influenza
8%Pain in extremity
8%Dizziness
7%Muscular weakness
7%Productive cough
7%Leukopenia
7%Infusion related reaction
7%Urinary tract infection
7%Constipation
7%Hypokalaemia
7%Rash
6%Lower respiratory tract infection
6%Pruritus
6%Fall
6%Musculoskeletal chest pain
6%Hypogammaglobulinaemia
6%Pharyngitis
6%Hypocalcaemia
6%Myalgia
6%Chills
5%COVID-19 pneumonia
5%COVID-19
5%Sinusitis
5%Contusion
5%Oropharyngeal pain
5%Conjunctivitis
5%Oedema
4%Tachycardia
4%Abdominal pain
4%Sepsis
3%Epistaxis
3%Acute kidney injury
3%Plasma cell myeloma
2%Atrial fibrillation
2%Septic shock
2%Pulmonary embolism
2%Pulmonary oedema
1%Syncope
1%Plasmacytoma
1%Osteonecrosis of jaw
1%Sudden death
1%Infection
1%Pneumonia respiratory syncytial viral
1%Blood creatinine increased
1%Pathological fracture
1%Pulmonary arterial hypertension
1%Pulmonary hypertension
1%Respiratory failure
1%Febrile neutropenia
1%Thrombotic thrombocytopenic purpura
1%Cardiac failure acute
1%Acute coronary syndrome
1%Cardiac failure
1%Myocardial ischaemia
1%Atrial flutter
1%Cardio-respiratory arrest
1%Bacteraemia
1%Upper gastrointestinal haemorrhage
1%Hepatic function abnormal
1%Lung infection
1%Cellulitis
1%Device related infection
1%Pneumonia cytomegaloviral
1%Respiratory syncytial virus infection
1%Hyperkalaemia
1%Tumour lysis syndrome
1%Viral infection
1%Overdose
1%Squamous cell carcinoma
1%Posterior reversible encephalopathy syndrome
1%Pleural effusion
1%Interstitial lung disease
1%Pneumonitis
1%Cardiac arrest
1%Myocardial infarction
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 39%, Hypertension with 37%, Anaemia with 37%, Diarrhoea with 36%, Upper respiratory tract infection with 34%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.

Trial Design

2 Treatment Groups

Arm I (DId)
1 of 2
Arm II (DVd, DId)
1 of 2

Experimental Treatment

49 Total Participants · 2 Treatment Groups

Primary Treatment: Daratumumab · No Placebo Group · Phase 2

Arm I (DId)Experimental Group · 3 Interventions: Ixazomib, Dexamethasone, Daratumumab · Intervention Types: Drug, Drug, Biological
Arm II (DVd, DId)Experimental Group · 4 Interventions: Ixazomib, Bortezomib, Dexamethasone, Daratumumab · Intervention Types: Drug, Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ixazomib
FDA approved
Bortezomib D-mannitol
FDA approved
Dexamethasone
FDA approved
Daratumumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years after study start

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,272 Previous Clinical Trials
41,230,679 Total Patients Enrolled
565 Trials studying Multiple Myeloma
193,046 Patients Enrolled for Multiple Myeloma
National Institutes of Health (NIH)NIH
2,550 Previous Clinical Trials
24,611,096 Total Patients Enrolled
15 Trials studying Multiple Myeloma
888 Patients Enrolled for Multiple Myeloma
Janssen, LPIndustry Sponsor
149 Previous Clinical Trials
202,274 Total Patients Enrolled
22 Trials studying Multiple Myeloma
3,236 Patients Enrolled for Multiple Myeloma
TakedaIndustry Sponsor
1,144 Previous Clinical Trials
4,057,484 Total Patients Enrolled
47 Trials studying Multiple Myeloma
18,141 Patients Enrolled for Multiple Myeloma
Emory UniversityLead Sponsor
1,558 Previous Clinical Trials
2,765,692 Total Patients Enrolled
24 Trials studying Multiple Myeloma
1,900 Patients Enrolled for Multiple Myeloma
Ajay Nooka, MD, MPHPrincipal Investigator - Emory University
Emory University Hospital, Emory University Hospital Midtown
Andhra Medical College (Medical School)
Canton Medical Educ Fndn (Residency)
2 Previous Clinical Trials
129 Total Patients Enrolled
2 Trials studying Multiple Myeloma
129 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

For what conditions are treatment regimens featuring Daratumumab commonly prescribed?

"Daratumumab has been clinically demonstrated to successfully treat ophthalmia, sympathetic conditions, branch retinal vein occlusions, and macular edema." - Anonymous Online Contributor

Unverified Answer

Has Daratumumab been officially sanctioned by the FDA?

"The safety of Daratumumab has been assessed as a 2, since the trial is currently at Phase 2 and there is data indicating its security but no evidence yet that it achieves desired results." - Anonymous Online Contributor

Unverified Answer

Could you provide a summary of the prior research performed regarding Daratumumab?

"At the present moment, there are 666 clinical trials dedicated to exploring Daratumumab. Of these studies, 153 have reached Phase 3 in their research while 21944 sites worldwide are running such experiments. Specifically, many of these locations lie within Mishawaka, Indiana." - Anonymous Online Contributor

Unverified Answer

How many participants is the trial looking to recruit?

"Affirmative. The study, first published on July 3rd 2019 and recently updated in December 2021, is actively recruiting according to clinicaltrials.gov. 76 participants need to be enrolled at 1 medical centre." - Anonymous Online Contributor

Unverified Answer

Is there still room for volunteers in this experiment?

"From clinicaltrials.gov, it is evident that this trial has reached its recruitment phase. Having been initially posted on July 3rd 2019, the data was last amended at the end of December 2021." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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