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Monoclonal Antibodies
Daratumumab + T Cell Redirecting Antibodies for Multiple Myeloma
Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) in any order during the treatment or have disease that is double refractory to a PI and an IMiD
Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to cycle 7 day 1 (each cycle of 28-days)
Awards & highlights
Study Summary
This trial is testing different doses of two drugs to see which are safe and effective in treating myeloma.
Who is the study for?
This trial is for adults with multiple myeloma who've had at least three prior treatments, including specific drugs like proteasome inhibitors and immunomodulatory drugs. They should be relatively healthy (ECOG grade of 0 or 1) and not pregnant if female. People can't join if they've recently used certain anti-CD38 therapies, received live vaccines, or have active hepatitis or central nervous system involvement by the cancer.Check my eligibility
What is being tested?
The study is testing combinations of Daratumumab with Talquetamab or Teclistamab, with some groups also getting Pomalidomide. The goal is to find safe doses for these combos and see how well they work together in treating multiple myeloma.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, immune system complications that may affect various organs, fatigue, nausea, blood count changes which could increase infection risk. Each person's reaction to treatment can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition did not improve after treatments including a PI and an IMiD.
Select...
My multiple myeloma diagnosis follows international guidelines.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to cycle 7 day 1 (each cycle of 28-days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to cycle 7 day 1 (each cycle of 28-days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Part 1: Number of Participants With Dose Limiting Toxicity by Severity
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
+1 moreSecondary outcome measures
Biomarker Assessment of Daratumumab
Biomarker Assessment of Talquetamab
Biomarker Assessment of Teclistamab
+10 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: Part 2: Dose ExpansionExperimental Treatment4 Interventions
Participants will be treated with the RP2D(s) for selected treatment combinations determined in Part 1.
Group II: Part 1: Dose EscalationExperimental Treatment4 Interventions
Participants will be assigned to either a combination of 1) daratumumab plus teclistamab or 2) daratumumab plus talquetamab or 3) daratumumab plus talquetamab plus pomalidomide or 4) daratumumab plus teclistamab plus pomalidomide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020
Daratumumab
2014
Completed Phase 3
~1860
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,019 Total Patients Enrolled
70 Trials studying Multiple Myeloma
19,128 Patients Enrolled for Multiple Myeloma
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,616 Total Patients Enrolled
49 Trials studying Multiple Myeloma
14,095 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had CD38 therapy in the last 3 months or stopped it due to side effects.I haven't had a live vaccine in the last 4 weeks or it was approved by the study sponsor.My condition did not improve after treatments including a PI and an IMiD.You have a positive test for hepatitis B or an active hepatitis C infection.You must have a specific amount of disease that can be measured according to certain rules.My multiple myeloma diagnosis follows international guidelines.I am fully active or restricted in physically strenuous activity but can do light work.My multiple myeloma has spread to my brain or spinal cord.Women who could become pregnant must have a negative pregnancy test before starting the study.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Dose Escalation
- Group 2: Part 2: Dose Expansion
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 are the principal ambitions of this medical experiment?
"This clinical trial, which will be conducted over up to 52 weeks, seeks to measure the number of participants with dose limiting toxicity. Secondary objectives include assessing time-to-response metrics and biomarker assessment of Talquetamab and serum concentration levels of Daratumumab."
Answered by AI
Are there other precedents of Daratumumab being tested in a laboratory setting?
"At the moment, 208 studies are underway to research Daratumumab. Of those ongoing trials, 32 have reached phase 3 and 7647 different sites across the world are running tests for this drug. Houston, Texas is particularly active in studying its effects."
Answered by AI
Are there any vacancies currently available in this clinical experiment?
"The information accessible on clinicaltrials.gov reveals that this trial is no longer recruiting patients; the announcement was first posted in February of 2020 and last updated in December 2022. Despite this, there are currently 1015 other studies seeking participants at this moment."
Answered by AI
What pathologies is Daratumumab typically administered to treat?
"Daratumumab is a common biological response modifier that helps address serious medical issues such as refractory multiple myeloma, relapsed or refractory multiple myeloma, and cellular transplants."
Answered by AI
What is the aggregate figure for trial participants enrolled in this research?
"At this time, the trial is not enrolling. It was initially posted on February 21st 2020 and last updated on December 1st 2022. Alternately, there are 807 studies recruiting patients with multiple myeloma and 208 trials for Daratumumab that have open enrollment periods."
Answered by AI
Has Daratumumab been given the green light by the FDA?
"At Power, we've assigned Daratumumab a score of 1 on our safety scale. This rating is due to its early phase study status and the restricted data supporting efficacy and security that exists at present."
Answered by AI
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