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Monoclonal Antibodies

Daratumumab + Lenalidomide for Multiple Myeloma

Phase 2
Recruiting
Led By Frank Passero, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A performance status ≤ 3
Female subjects of child bearing potential must be surgically sterile, be post-menopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial will test the effectiveness of daratumumab and lenalidomide in treating multiple myeloma without the use of steroids.

Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who haven't had previous treatments and can't have a transplant. They should be able to take oral meds, not be pregnant or breastfeeding, and must not have other severe health issues or recent major surgeries.Check my eligibility
What is being tested?
The study tests the effectiveness of daratumumab and lenalidomide without steroids in treating multiple myeloma. It aims to see if patients can avoid steroid-related side effects while still controlling their cancer effectively.See study design
What are the potential side effects?
Possible side effects include immune system reactions, infusion-related reactions from daratumumab, blood clots due to lenalidomide, as well as potential risks like infections, fatigue, nausea, diarrhea, and rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself but cannot do any physical work.
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I am a woman who cannot become pregnant because I am either surgically sterile or post-menopausal.
Select...
My organs are functioning well.
Select...
I can swallow and keep down pills.
Select...
I have been recently diagnosed and am not eligible for high-dose chemotherapy.
Select...
I have not been treated for multiple myeloma before.
Select...
I have been diagnosed with multiple myeloma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Daratumumab Related Infusion Reactions
Secondary outcome measures
Determination of Response Rates

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
9%
Bone pain
9%
Leukopenia
9%
Urinary tract infection
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Alanine aminotransferase increased
8%
Abdominal pain upper
8%
Weight decreased
8%
Muscle Spasms
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Aspartate aminotransferase increased
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Abdominal pain
6%
Nasal congestion
5%
Bone Pain
5%
Throat irritation
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Squamous cell carcinoma of skin
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Acute myocardial infarction
1%
Pulmonary sepsis
1%
Pleural effusion
1%
Febrile neutropenia
1%
Acute coronary syndrome
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Femur fracture
1%
Pathological fracture
1%
Pneumonia cytomegaloviral
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Respiratory failure
1%
Bronchitis chronic
1%
Gastroenteritis
1%
Humerus 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

3Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Arm: Cycle 5+ Partial Response or BetterExperimental Treatment2 Interventions
Subjects will be treated the following: Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks Lenalidomide 25 milligrams/kilograms daily days 1-21 out of a 28 day cycle
Group II: Experimental Arm: Cycle 1-4 All subjectsActive Control3 Interventions
Subjects will be treated with the following: Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
Group III: Experimental Arm: Cycle 5+ Less than Partial ResponseActive Control3 Interventions
Subjects will be treated the following: Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1860
Lenalidomide
2005
Completed Phase 3
~1480

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
834 Previous Clinical Trials
518,264 Total Patients Enrolled
11 Trials studying Multiple Myeloma
298 Patients Enrolled for Multiple Myeloma
Frank Passero, MDPrincipal Investigator - University of Rochester
Delaware County Memorial Hospital
University Of Pennsylvania School Of Medicine (Medical School)
Pa Hospital-Uphs (Residency)

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04635189 — Phase 2
Multiple Myeloma Research Study Groups: Experimental Arm: Cycle 1-4 All subjects, Experimental Arm: Cycle 5+ Less than Partial Response, Experimental Arm: Cycle 5+ Partial Response or Better
Multiple Myeloma Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT04635189 — Phase 2
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04635189 — Phase 2

Frequently Asked Questions

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

What symptoms is Daratumumab typically prescribed to alleviate?

"Daratumumab is generally prescribed as a treatment for ophthalmia, sympathetic. It can also be utilized to address branch retinal vein occlusion and macular edema in patients who have experienced at least two rounds of systemic chemotherapy."

Answered by AI

How many participants are being admitted to this clinical research?

"Affirmative. According to information on clinicaltrials.gov, this medical trial is presently seeking participants and was first published on July 27th 2021 with a subsequent update date of July 8th 2022. The research will require 28 individuals at one site for completion."

Answered by AI

Have any other investigations been conducted involving Daratumumab?

"Currently, 745 studies are in progress for Daratumumab with 169 of them classified as Phase 3. Most experiments occur in Joliet, Illinois although there are 26198 locations worldwide running trials involving this medication."

Answered by AI

Am I eligible to contribute to this research endeavor?

"This clinical research is searching for 28 individuals between 18 and 75 with multiple myeloma. In addition to this, the participants must be newly diagnosed, surgically sterile or post-menopausal (if female), not have received therapy before, and have a performance status of 3 or less in order to qualify."

Answered by AI

Is there any risk associated with Daratumumab treatments?

"While there is a limited data set to support the safety of daratumumab, no evidence exists that demonstrates efficacy. So, our team at Power rated it as a 2 on their scale from 1 to 3."

Answered by AI

Are participants over the age of sixty eligible for enrollment in this research project?

"This research is targeting individuals between 18 and 75 years of age."

Answered by AI

Is it currently feasible for volunteers to join this experiment?

"Correct. Clinicaltrials.gov information indicates that this trial is actively recruiting, with the first listing being published on July 27th 2021 and recently edited on July 8th 2022. They are searching to enroll 28 individuals from one site location."

Answered by AI
~3 spots leftby Jul 2024