Daratumumab for Multiple Myeloma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Multiple MyelomaDaratumumab - Drug
Eligibility
18 - 79
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding daratumumab to lenalidomide can help people with newly diagnosed multiple myeloma who are positive for MRD (as determined by next generation sequencing).

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Up to 4.1 years

Year 3
Change in HRQoL as Measured by EORTC QLQ-Multiple Myeloma Module (MY20)
Change in HRQoL as Measured by European Quality of Life Five Dimensions Questionnaire-5-level (EQ-5D-5L)
Change in Health-Related Quality of Life (HRQoL) as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30
Up to 12 months
Percentage of Participants with Minimal Residual Disease (MRD) Negative Status as determined by NGS
Up to 3 years
Durable MRD Negative Rate
Duration of Complete Response (CR)
Percentage of Participants Achieving Complete Response (CR) or Stringent Complete Response (sCR)
Percentage of Participants with Overall Minimal Residual Disease (MRD) Negative Status
Progression-free Survival (PFS)
Up to 4.1 years
Therapeutic procedure
Overall Survival (OS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% 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%Decreased appetite
9%Hyperglycaemia
9%Respiratory tract infection
9%Lymphopenia
9%Asthenia
9%Nasopharyngitis
8%Neuropathy peripheral
8%Arthralgia
7%Productive cough
7%Infusion related reaction
7%Constipation
7%Influenza
7%Dizziness
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

Lenalidomide
1 of 2
Daratumumab + Lenalidomide
1 of 2

Active Control

Experimental Treatment

214 Total Participants · 2 Treatment Groups

Primary Treatment: Daratumumab · No Placebo Group · Phase 3

Daratumumab + LenalidomideExperimental Group · 2 Interventions: Daratumumab, Lenalidomide · Intervention Types: Drug, Drug
Lenalidomide
Drug
ActiveComparator Group · 1 Intervention: Lenalidomide · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved
Lenalidomide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4.1 years

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
926 Previous Clinical Trials
6,345,945 Total Patients Enrolled
65 Trials studying Multiple Myeloma
17,386 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
712 Previous Clinical Trials
3,918,930 Total Patients Enrolled
47 Trials studying Multiple Myeloma
12,480 Patients Enrolled for Multiple Myeloma

Eligibility Criteria

Age 18 - 79 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The participant must have a very good partial response (VGPR) or better response assessed per International Myeloma Working Group (IMWG) 2016 criteria at the time of randomization.
Must have a cancer that is not currently treated with radiation therapy Cannot have received other investigational agents for the treatment of the selected cancer in the last 4 weeks Cannot have received prior treatment with lucitanib This patient must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 and a cancer that is not currently treated with radiation therapy
Subjects must have newly diagnosed multiple myeloma and a history of 4 cycles of induction therapy, including HDT and ASCT within 12 months of the start of induction therapy, and be ≤6 months from ASCT at the time of randomization.