All > Oregon > Missouri

Daratumumab for Plasma Cell Myeloma

Siteman Cancer Center at Christian Hospital, Saint Louis, MO
Plasma Cell MyelomaDaratumumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing Lenalidomide + Dexamethasone with or without Daratumumab to see if it can better treat patients with high-risk smoldering myeloma.

Eligible Conditions
  • Smoldering Plasma Cell Myeloma

Treatment Effectiveness

Phase-Based Effectiveness

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

Similar Trials

1
Romosozumab
1
Daratumumab
1
Daratumumab

Study Objectives

2 Primary · 10 Secondary · Reporting Duration: Up to 15 years

Day 28
Stem cell (SC) mobilization failure
Day 28
Presence, frequency, interference, amount and/or severity of select patient reported outcomes (PRO)-CTCAEs
Month 24
Best response on treatment based on International Myeloma Working Group (IMWG) criteria
Day 28
Adherence Starts with Knowledge (ASK)-12 scores
Day 28
Functional Assessment of Cancer Therapy-General (FACT-G) score
Day 28
Type of growth factor support
Day 28
Incidence of grade 3 or higher infusion-related reactions over course 1 determined based on CTCAE
Month 6
Time to worsening of FACT-G
Day 28
Levels of FACT-G score at each assessment time point
Month 24
Duration of treatment
Year 15
Overall survival (OS)
Year 15
Time to progression
Year 15
Progression-free survival (PFS)
Month 6
Change in FACT-G score
Up to 15 years
Overall PRO-CTCAE score
PRO completion rate
PRO compliance rate
Up to 24 months
Cumulative dose calculated as the sum of all doses taken across all cycles
Dose intensity calculated as cumulative dose received divided by treatment duration
Relative dose intensity calculated as the dose intensity divided by planned dose intensity
Day 28
Incidence of adverse events by worst grade and type for treated patients determined using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Day 28
Early SC mobilization feasibility

Trial Safety

Phase-Based Safety

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

Similar Trials

1
Romosozumab
2
Daratumumab
2
Daratumumab

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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 (daratumumab, lenalidomide, dexamethasone)
1 of 2
Arm II (lenalidomide, dexamethasone)
1 of 2

Experimental Treatment

288 Total Participants · 2 Treatment Groups

Primary Treatment: Daratumumab · No Placebo Group · Phase 3

Arm I (daratumumab, lenalidomide, dexamethasone)Experimental Group · 4 Interventions: Dexamethasone, Questionnaire Administration, Lenalidomide, Daratumumab · Intervention Types: Drug, Other, Drug, Biological
Arm II (lenalidomide, dexamethasone)Experimental Group · 4 Interventions: Dexamethasone, Questionnaire Administration, Lenalidomide, Quality-of-Life Assessment · Intervention Types: Drug, Other, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Lenalidomide
FDA approved
Daratumumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
110 Previous Clinical Trials
173,406 Total Patients Enrolled
2 Trials studying Plasma Cell Myeloma
2,537 Patients Enrolled for Plasma Cell Myeloma
National Cancer Institute (NCI)NIH
13,272 Previous Clinical Trials
41,230,440 Total Patients Enrolled
70 Trials studying Plasma Cell Myeloma
24,092 Patients Enrolled for Plasma Cell Myeloma
Natalie S CallanderPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Michigan100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

How many test subjects are actively participating in this experiment?

"Indeed, the clinicaltrials.gov website contains information indicating that this study is recruiting patients. This particular trial was first posted on April 30th, 2019 and was last edited on December 1st, 2021. A total of 288 participants are needed for the study, which is taking place at 100 different sites." - Anonymous Online Contributor

Unverified Answer

Are there any precedents for Daratumumab's usage in medical research?

"Manitoba Blood & Marrow Transplant Program CancerCare Manitoba was the first to study daratumumab in 2002. As of now, there are 1596 completed studies and 776 live trials being conducted, many of which taking place in Lakewood, Colorado." - Anonymous Online Contributor

Unverified Answer

What is the lofty goal of this clinical trial?

"The goal of this clinical trial is to measure overall survival (OS) over a 24-cycle treatment period (each cycle lasting 28 days). Secondary outcomes include the incidence of grade 3 or higher infusion-related reactions during cycle 1, as well as the rates of worst grade 3 or higher non-hematologic treatment-related events. Response rates of very good partial response (VGPR) or better and partial response (PR) or better will also be compared. ineligible patients are excluded from the analysis and unevaluable patients are counted in the denominator. Lastly, progression-free survival (PFS) will be estimated using the" - Anonymous Online Contributor

Unverified Answer

Has Daratumumab been cleared by the FDA?

"Daratumumab is considered safe according to our team's estimation, as it has received a score of 3. This is because phase 3 trials have shown some efficacy and multiple rounds of data supporting safety." - Anonymous Online Contributor

Unverified Answer

What are some of the key ways that Daratumumab has been shown to be effective?

"Most often, Daratumumab is used to treat ophthalmia and sympathetic. However, it has also been shown to be effective in treating branch retinal vein occlusion, macular edema, and at least two prior systemic chemotherapy regimens." - 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.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top