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Daratumumab Combo for Multiple Myeloma
Phase 2
Waitlist Available
Led By Noa Biran, MD
Research Sponsored by Hackensack Meridian Health
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 12 months
Awards & highlights
Study Summary
This trial is testing a new drug combo to see if it's safe and effective in treating people with myeloma.
Who is the study for?
This trial is for adults over 18 with relapsed multiple myeloma, who've had certain treatments before and showed at least stable disease. They must have a life expectancy of more than 3 months, be able to perform daily activities (ECOG PS 0-2), and use effective birth control if they can have children. People with major illnesses, recent cancers (except skin cancer), or positive tests for HIV or hepatitis won't qualify.Check my eligibility
What is being tested?
The study is testing the combination of Daratumumab with Pomalidomide, Dexamethasone, and All-Transretinoic Acid in patients who have previously been treated for multiple myeloma. It aims to see how safe this mix is and how well it works against the disease.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion of Daratumumab such as fever or chills; blood disorders; increased risk of infections; fatigue from Dexamethasone; skin changes due to All-trans retinoic acid; and potential heart or lung issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events
Objective Response Rate (Cohort A)
Secondary outcome measures
Best Stringent Complete Response
Duration of Response (DOR)
Incidence of Treatment-Emergent Adverse Events
+6 moreSide effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613460%
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
2Treatment groups
Experimental Treatment
Group I: Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)Experimental Treatment4 Interventions
Patients with relapsed or refractory multiple myeloma who have progressed on the combination of Dara + Pom + Dex (Cohort B) to be treated with a combination of Dara + Pom + Dex + ATRA (All-Transretinoic Acid)
Group II: Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)Experimental Treatment4 Interventions
Patients with relapsed or refractory multiple myeloma who have progressed on the combination of Dara + Len + Dex (Cohort A) to be treated with a combination of Dara + Pom + Dex + ATRA (All-Transretinoic Acid)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Daratumumab
2014
Completed Phase 3
~1860
Pomalidomide
2011
Completed Phase 2
~1020
All-trans retinoic acid
2012
Completed Phase 3
~1050
Find a Location
Who is running the clinical trial?
Hackensack Meridian HealthLead Sponsor
131 Previous Clinical Trials
28,243 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,419 Patients Enrolled for Multiple Myeloma
Janssen, LPIndustry Sponsor
160 Previous Clinical Trials
307,989 Total Patients Enrolled
23 Trials studying Multiple Myeloma
9,181 Patients Enrolled for Multiple Myeloma
Noa Biran, MDPrincipal InvestigatorHackensack Meridian Health
3 Previous Clinical Trials
162 Total Patients Enrolled
3 Trials studying Multiple Myeloma
162 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 3 more months.You have been diagnosed with multiple myeloma that has come back and can be measured.You have a performance status score between 0 and 2 according to the ECOG scale.You are 18 years old or older.You have plasma cell leukemia.You are HIV-positive.You have a condition called GVHD and are currently taking corticosteroids for it after a specific type of transplant.You have pressure on your spinal cord or your central nervous system is involved.You have had cancer that needed treatment within the past 2 years, except for non-melanoma skin cancer.You had a very severe allergic reaction to daratumumab or a type of medication called an IMiD in the past.Women who could become pregnant need to have two negative pregnancy tests before joining the study.You have hepatitis C, unless you have been successfully treated for it and the virus has been undetectable for at least 12 weeks.You have COPD with a breathing test result showing less than 50% of normal lung function.You have been diagnosed with multiple myeloma and it is documented in your medical records.You have hepatitis B, or have had it in the past, and your viral levels are too high. If you've been vaccinated for hepatitis B and have a positive anti-HBs test, you don't need the HBV DNA test.For group A, patients must have previously taken Dara+Len+Dex and their condition did not get worse while on this treatment.For group B, patients must have taken Dara + Pom + Dex and must have shown at least stable disease with this combination.Your organs (bone marrow, kidneys, liver, lungs, and heart) are working properly according to the most recent check-up.
Research Study Groups:
This trial has the following groups:- Group 1: Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
- Group 2: Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What possible risks does Daratumumab pose to individuals?
"Despite not having any clinical data to attest its efficacy, Daratumumab is still considered moderately safe and thus was allotted a score of 2."
Answered by AI
In what medical scenarios is Daratumumab typically prescribed?
"Daratumumab is primarily employed to combat ophthalmia and sympathetic, yet it may also be demanded for medical cases such as branch retinal vein occlusion, macular edema, or communicable illnesses."
Answered by AI
Is it still possible to join this experiment?
"According to information hosted on clinicaltrials.gov, this research initiative is actively seeking patients for enrollment. The trial was initially posted back in May 2nd 2022 and the most recent amendment occurred on June 10th of the same year."
Answered by AI
How many individuals can participate in this investigation?
"Affirmative. According to clinicaltrials.gov, the research project which was initially made available on May 2nd 2022 is currently seeking participants. The trial necessitates 43 patients from a single site for completion."
Answered by AI
What is the ultimate goal of this experiment?
"This research trial, planned to last for a year, will assess the Objective Response Rate (Cohort A) at its conclusion. Additionally, secondary objectives include determining Best Stringent Complete Response rates, quantifying Treatment-Emergent Adverse Events using CTCAE V5 criteria and evaluating the efficacy of Dara + Pom + Dex + ATRA in patients who have progressed on Dara + Pom + Dex therapy through measuring the Objective Response Rate (Cohort B)."
Answered by AI
Have prior experiments been conducted with Daratumumab?
"Currently, 638 clinical trials are being conducted for Daratumumab. Out of those, 152 have reached the Phase 3 stage and are taking place in Joliet, Illinois as well as 20 other sites around the world."
Answered by AI
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