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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Anti-CD38 mAb-naive RRMM subjects will be enrolled from ex-US countries
Dose Escalation phase, Expansion part A (for MM and AML) and Expansion part B- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
Study Summary
This trial is a safety trial of GEN3014, a new drug. The trial has two parts: a dose escalation part, which is the first time the drug will be used in humans, and an expansion part.
Who is the study for?
This trial is for adults with certain blood cancers like multiple myeloma or acute myeloid leukemia that have come back or didn't respond to treatment. They should be in a stable condition, not pregnant, and willing to use birth control. People can't join if they've had recent cancer treatments, stem cell transplants, active infections like hepatitis B/C or HIV, central nervous system involvement by the cancer, or are taking other experimental drugs.Check my eligibility
What is being tested?
The trial tests GEN3014 (an antibody) for safety and effectiveness in relapsed/refractory blood cancers. It has three parts: finding a safe dose level (Dose Escalation), testing this dose further (Expansion Part A), and comparing GEN3014 with daratumumab (Expansion Part B). Participants will receive either GEN3014 or daratumumab but no placebos.See study design
What are the potential side effects?
Possible side effects of GEN3014 aren't fully known since it's new but may include reactions at the infusion site, immune-related issues due to antibody action on the body's cells, fatigue, nausea, and potential impact on blood counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have never received anti-CD38 monoclonal antibodies for my relapsed or refractory multiple myeloma, and I live outside the US.
Select...
I am able to care for myself and can do some daily activities.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My multiple myeloma is worsening despite recent treatment.
Select...
I am a man who will use birth control and not donate sperm during and for 12 months after the trial.
Select...
I have had at least 2 treatments for my multiple myeloma and stopped daratumumab or isatuximab 4 weeks ago.
Select...
I've had 2 or more treatments for my condition, including one with CD20 therapy.
Select...
I have had a recent bone marrow sample taken.
Select...
I have AML and have been treated with at least 2 therapies, not including hydroxyurea.
Select...
I have relapsed or refractory multiple myeloma and have tried all standard treatments.
Select...
I agree to use birth control during and for a year after the trial.
Select...
I can provide a sample of my tumor for testing.
Select...
My AML has not responded to standard treatments.
Select...
I have AML and have been treated before, but not just with hydroxyurea.
Select...
My DLBCL has returned or didn't respond to treatment, and I've tried all standard treatments.
Select...
My blood or urine tests show signs of myeloma.
Select...
I have had at least 3 treatments for my multiple myeloma, including specific types or am resistant to two types.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)
Expansion Part A: Objective Response Rate (ORR) of GEN3014
+1 moreSecondary outcome measures
Dose Escalation: Accumulation Ratio in AUC (RA, AUC)
Dose Escalation: Accumulation Ratio in Cmax (RA, Cmax)
Dose Escalation: Area Under the Concentration Time Curve From Zero to 168 hours (AUC0-168 h)
+36 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%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Nasal congestion
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
Active Control
Group I: GEN3014Experimental Treatment1 Intervention
Experimental: GEN3014 Participants in Dose Escalation phase with
Relapsed or refractory myeloid myeloma (RRMM)
R/R acute myeloid leukemia (AML)
Participants in Expansion Part A with
RRMM (anti-CD38 mAb-naïve)
RRMM (anti-CD38 mAb-refractory)
R/R diffuse large B-cell lymphoma (DLBCL)
R/R AML
Participants in Expansion Part B with
• RRMM (anti-CD38 mAb-naïve)
Group II: DaratumumabActive Control1 Intervention
Participants in Expansion Part B with
- RRMM (anti-CD38 mAb-naïve)
Find a Location
Who is running the clinical trial?
GenmabLead Sponsor
56 Previous Clinical Trials
11,980 Total Patients Enrolled
Study OfficialStudy DirectorGenmab
9 Previous Clinical Trials
2,377 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who could become pregnant must have a negative pregnancy test before starting the study treatment. If you are in the Expansion Part B, you need to have a negative pregnancy test within 72 hours before starting the treatment.I have never received anti-CD38 monoclonal antibodies for my relapsed or refractory multiple myeloma, and I live outside the US.I have a serious heart condition.I have an ongoing or past hepatitis C infection that hasn't been cured.I had a stem cell transplant from a donor within the last 3 months.I am able to care for myself and can do some daily activities.Side effects from my past cancer treatments have mostly gone away, except for hair loss and nerve issues.There are very few immature blood cells in your blood or bone marrow at the time of screening.My cancer has spread to my brain.I am fully active or restricted in physically strenuous activity but can do light work.You have a history of hepatitis B.My multiple myeloma is worsening despite recent treatment.I have had a stem cell transplant from a donor.I am a man who will use birth control and not donate sperm during and for 12 months after the trial.I have taken less than 140 mg of prednisone or 160 mg of dexamethasone recently.You need to have at least one area of your disease that can be measured according to specific criteria.I have had at least 2 treatments for my multiple myeloma and stopped daratumumab or isatuximab 4 weeks ago.I've had 2 or more treatments for my condition, including one with CD20 therapy.I have had a recent bone marrow sample taken.I have AML and have been treated with at least 2 therapies, not including hydroxyurea.I have relapsed or refractory multiple myeloma and have tried all standard treatments.I agree to use birth control during and for a year after the trial.I can provide a sample of my tumor for testing.I have a condition where my transplanted cells attack my body, and I haven't taken any immune-suppressing drugs in the last 4 weeks.I have not received CD38-targeted treatments for my multiple myeloma.I haven't had cancer treatment or major surgery in the last 2 weeks.I have had a stem cell transplant using my own cells.My AML has not responded to standard treatments.I have AML and have been treated before, but not just with hydroxyurea.My DLBCL has returned or didn't respond to treatment, and I've tried all standard treatments.I had a stem cell transplant using my own cells within the last 3 months.I plan to try for a child during or within a year after the study.You have a history of testing positive for HIV.My blood or urine tests show signs of myeloma.I have had at least 3 treatments for my multiple myeloma, including specific types or am resistant to two types.
Research Study Groups:
This trial has the following groups:- Group 1: GEN3014
- Group 2: Daratumumab
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.
Are there any opportunities for volunteers to participate in this clinical trial currently?
"Affirmative. Clinicaltrials.gov has evidence that this experiment is recruiting patients at present; it was initially posted on March 22nd 2021 and modified most recently on September 1st 2021. 152 subjects have to be sourced from 3 different sites for the trial's completion."
Answered by AI
How many patients are involved in the research project?
"To complete the research, Genmab requires 152 participants who fit the criteria of inclusion. The sponsor will be holding this trial in various locations including Medical College of Wisconsin at Milwaukee, WI and Hackensack University Medical Center located in New jersey."
Answered by AI
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