Daratumumab for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Multiple MyelomaDaratumumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing daratumumab, hyaluronidase-fihj, and pomalidomide to see if they work well together to treat patients with relapsed multiple myeloma.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: From the date of initiation of maintenance therapy assessed up to 2 years

At course 6 of therapy
Complete remission rate (CRR) defined as achieving a negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow
Year 2
Progression-free survival (PFS)

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

1 Treatment Group

Treatment (daratumumab)
1 of 1

Experimental Treatment

56 Total Participants · 1 Treatment Group

Primary Treatment: Daratumumab · No Placebo Group · Phase 2

Treatment (daratumumab)
Biological
Experimental Group · 1 Intervention: Daratumumab · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of initiation of maintenance therapy assessed up to 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,077 Previous Clinical Trials
41,139,572 Total Patients Enrolled
556 Trials studying Multiple Myeloma
193,150 Patients Enrolled for Multiple Myeloma
M.D. Anderson Cancer CenterLead Sponsor
2,805 Previous Clinical Trials
1,790,478 Total Patients Enrolled
72 Trials studying Multiple Myeloma
5,668 Patients Enrolled for Multiple Myeloma
Muzaffar H QazilbashPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have ALT and/or AST levels within the normal range (within 5 days before the first dose of the study drug).
You have relapsed or have had a previous autologous stem cell transplant (ASCT) followed by relapse
You must have voluntary written informed consent before performance of any study-related procedure not part of normal medical care must be obtained, with the understanding that consent may be withdrawn by the subject at any time without any prejudice to future medical care.