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Monoclonal Antibodies

Daratumumab for Multiple Myeloma

Phase 2
Waitlist Available
Led By Sham Mailankody, MBBS
Research Sponsored by Memorial Sloan Kettering Cancer Center
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 6 months
Awards & highlights

Study Summary

This trial is testing the safety of combining Daratumumab with Lenalidomide, and looking for any effects on people with Multiple Myeloma. Additionally, it is testing how well Daratumumab works at reducing the amount of remaining myeloma cells (minimal residual disease, or MRD).

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With MRD Negativity by the Completion of 6 Months of Daratumumab Therapy

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%
Lymphopenia
14%
Pain in extremity
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%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Nasal congestion
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Abdominal pain
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Febrile neutropenia
1%
Acute coronary syndrome
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Respiratory failure
1%
Bronchitis chronic
1%
Squamous cell carcinoma of skin
1%
Humerus fracture
1%
Gastroenteritis
1%
Femur fracture
1%
Pleural effusion
1%
Pathological fracture
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Multiple MyelomaExperimental Treatment2 Interventions
Participants with MM with very good partial response (VGPR) or better after induction therapy with/without consolidative HDT/ASCT and MRD positive by bone marrow flow cytometry and MM participants who were previously MRD negative after induction and consolidation and recently (within last 3 months) turned MRD positive by bone marrow flow cytometry will be enrolled.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Daratumumab
2014
Completed Phase 3
~1860

Find a Location

Who is running the clinical trial?

Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,508 Total Patients Enrolled
23 Trials studying Multiple Myeloma
2,086 Patients Enrolled for Multiple Myeloma
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,935 Previous Clinical Trials
588,845 Total Patients Enrolled
80 Trials studying Multiple Myeloma
86,157 Patients Enrolled for Multiple Myeloma
Sham Mailankody, MBBSPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
72 Total Patients Enrolled
4 Trials studying Multiple Myeloma
72 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

Have there been any other experiments done utilizing Daratumumab?

"Currently, there are 360 Daratumumab studies in session with 70 of those being Phase 3. Although there is a cluster of said trials occurring in Chicago Illinois, the medication can be tested at nearly 16000 sites around the world."

Answered by AI

Is enrollment for this research project still available to participants?

"This clinical trial is not presently accepting new patients. Posted on May 3, 2018 and last updated on July 8th 2022, the study is no longer active. However, there are currently 807 medical trials actively enrolling those with multiple myeloma and 360 trials recruiting for Daratumumab therapies."

Answered by AI

How many participants are engaged in this research endeavor?

"Recruitment for this trial is no longer available. It was originally posted on May 3rd, 2018 and had its last update recorded on July 8th 2022. For those seeking alternate studies, there are presently 807 clinical trials related to multiple myeloma actively enrolling patients and 360 research programmes that involve Daratumumab recruiting participants."

Answered by AI

Are there multiple facilities conducting this investigation in the U.S.?

"This trial is recruiting from 7 medical centres, including Memorial Sloan Kettering Nassau in Uniondale, Memoral Sloan Kettering Monmouth in Middletown and Basking Ridge. Additionally, 4 other locations are also participating."

Answered by AI

In what cases is Daratumumab typically prescribed?

"Individuals with chronic lymphocytic leukemia who have experienced immunomodulation and two prior chemotherapy regimens can potentially benefit from Daratumumab."

Answered by AI

Has Daratumumab been given the green light by the FDA?

"Because of the lack of clinical data confirming its efficacy, Daratumumab is rated at a 2 out of 3 for safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Short Course Daratumumab in Patients With Multiple Myeloma
2018. "Short Course Daratumumab in Patients With Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03490344.
~1 spots leftby Apr 2025
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