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Kinase Inhibitor

Daratumumab for Waldenstrom's Macroglobulinemia

Q: Is this research project looking for new participants right now?

Yes, the study is still looking for patients. According to clinicaltrials.gov, the trial was first posted on 7/30/2020 and recruitment will close once they have 24 participants from 1 location.

Q: What other research exists on Daratumumab's effects?

Currently, there are 296 separate clinical trials investigating Daratumumab with 49 of those in Phase 3. Most of these studies originate from Karlsruhe and Quebec; however, 12760 locations worldwide are researching Daratumumab.

Q: What are some common indications for Daratumumab?

Daratumumab is frequently used to treat biological response modifiers. However, it can also be given as a course of treatment for refractory <a href="https://www.withpower.com/clinical-trials/multiple-myeloma">multiple myeloma</a>, relapsed or refractory multiple myeloma, and cell transplants.

Q: Has Daratumumab been cleared by the FDA?

There is some data suggesting that Daratumumab is safe, but none to support its efficacy. Our team has given it a score of 2.

Q: How many individuals are taking part in this research project?

That is correct. The clinical trial was posted on 30 July 2020 and is currently recruiting patients for the study. Last edited on 21 December 2021, the study plans to enroll 24 individuals at a single location.

Phase 2

Waitlist Available

Led By John N. Allan, M.D.

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of adding the drug daratumumab to ibrutinib for patients with Waldenstrӧm's macroglobulinemia. There will be two groups of patients: those who are new to ibrutinib and those who have been taking ibrutinib but are not responding well to it.

Eligible Conditions

Waldenstrom's Macroglobulinemia
Waldenstrom's Macroglobulinaemia
Waldenstrom Macroglobulinemia
Waldenström Macroglobulinemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of Combination Treatment With Ibrutinib and Daratumumab as Measured by the Number of Patients That Experience 1 or More Adverse Event

Secondary outcome measures

Deepening of Response Rate in Cohort B After Daratumumab Addition

Duration of Response

Major Response Rate in Cohort A

+3 more

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134

60%

Thrombocytopenia

50%

Peripheral sensory neuropathy

47%

Peripheral Sensory Neuropathy

36%

Upper respiratory tract infection

36%

Diarrhoea

29%

Cough

28%

Anaemia

23%

Fatigue

23%

Upper Respiratory Tract Infection

23%

Constipation

21%

Back pain

20%

Arthralgia

20%

Oedema peripheral

19%

Neutropenia

19%

Dyspnoea

18%

Insomnia

17%

Pyrexia

16%

Oedema Peripheral

15%

Nausea

14%

Pain in extremity

14%

Lymphopenia

14%

Nasopharyngitis

14%

Bronchitis

14%

Neuralgia

13%

Back Pain

13%

Dizziness

12%

Decreased appetite

12%

Vomiting

12%

Headache

12%

Hypertension

11%

Conjunctivitis

11%

Asthenia

11%

Pneumonia

11%

Hypokalaemia

10%

Musculoskeletal chest pain

10%

Muscle spasms

Bone pain

Leukopenia

Urinary tract infection

Decreased Appetite

Hyperglycaemia

Pain in Extremity

Bronchospasm

Alanine aminotransferase increased

Abdominal pain upper

Weight decreased

Muscle Spasms

Hypophosphataemia

Herpes zoster

Influenza

Hypocalcaemia

Alanine Aminotransferase Increased

Rash

Aspartate aminotransferase increased

Musculoskeletal Chest Pain

Myalgia

Abdominal pain

Nasal congestion

Bone Pain

Throat irritation

Hypotension

Abdominal Pain Upper

Weight Decreased

Chills

Productive cough

Herpes Zoster

Oedema

Paraesthesia

Epistaxis

Dyspepsia

Atrial fibrillation

Acute kidney injury

Sepsis

Atrial Fibrillation

Acute myocardial infarction

Humerus fracture

Pneumonia cytomegaloviral

Squamous cell carcinoma of skin

Rib fracture

Lower Respiratory Tract Infection

Pulmonary sepsis

Pathological fracture

Febrile neutropenia

Pleural effusion

Acute coronary syndrome

Pulmonary Sepsis

Hypercalcaemia

Pneumonia Cytomegaloviral

Cardiac failure congestive

Femur fracture

Lower respiratory tract infection

Hip fracture

Angina unstable

Cerebrovascular accident

Ischaemic stroke

Respiratory failure

Bronchitis chronic

Gastroenteritis

Ischaemic Stroke

Respiratory Failure

Pathological Fracture

Febrile Neutropenia

Cardiac Failure Congestive

Bronchopneumonia

Femur Fracture

Humerus Fracture

Acute Kidney Injury

Pleural Effusion

100%

80%

60%

40%

20%

Study treatment Arm

Daratumumab + Bortezomib and Dexamethasone (DVd)

Bortezomib + Dexamethasone (Vd)

Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B - Ibrutinib response plateauExperimental Treatment2 Interventions

Cohort B will consist of subjects who have had at least 6 months of exposure to single agent ibrutinib and who have demonstrated an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed <15% from the previous mark. All subjects in this cohort will receive ibrutinib plus daratumumab

Group II: Cohort A - Ibrutinib naiveExperimental Treatment2 Interventions

Cohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ibrutinib

2014

Completed Phase 3

~1880

Daratumumab

2014

Completed Phase 3

~1860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Janssen Scientific Affairs, LLCIndustry Sponsor

158 Previous Clinical Trials

579,701 Total Patients Enrolled

Mayo ClinicOTHER

3,200 Previous Clinical Trials

3,760,894 Total Patients Enrolled

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,644 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project looking for new participants right now?

"Yes, the study is still looking for patients. According to clinicaltrials.gov, the trial was first posted on 7/30/2020 and recruitment will close once they have 24 participants from 1 location."

Answered by AI

What other research exists on Daratumumab's effects?

"Currently, there are 296 separate clinical trials investigating Daratumumab with 49 of those in Phase 3. Most of these studies originate from Karlsruhe and Quebec; however, 12760 locations worldwide are researching Daratumumab."

Answered by AI

What are some common indications for Daratumumab?

"Daratumumab is frequently used to treat biological response modifiers. However, it can also be given as a course of treatment for refractory multiple myeloma, relapsed or refractory multiple myeloma, and cell transplants."

Answered by AI

Has Daratumumab been cleared by the FDA?

"There is some data suggesting that Daratumumab is safe, but none to support its efficacy. Our team has given it a score of 2."

Answered by AI

How many individuals are taking part in this research project?

"That is correct. The clinical trial was posted on 30 July 2020 and is currently recruiting patients for the study. Last edited on 21 December 2021, the study plans to enroll 24 individuals at a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia

2020. "Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03679624.