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Monoclonal Antibodies
Nivolumab + Daratumumab for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have received at least 3 prior lines of therapy, including a proteasome inhibitor [PI] and an immunomodulatory agent [IMiD] OR have disease that is double refractory to a PI and IMiD
More than 12 weeks post-transplant of your own blood forming stem cells (autologous transplant)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately up to 4 years
Awards & highlights
Study Summary
This trial will test the side effects of a new combination treatment for relapsed or refractory multiple myeloma.
Who is the study for?
This trial is for people with multiple myeloma who've had at least three prior treatments or whose disease resisted both proteasome inhibitors and immunomodulatory drugs. Participants must have measurable disease, be over 12 weeks post-autologous transplant, and agree to a bone marrow test.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining two immune therapy drugs, Nivolumab and Daratumumab, in patients with relapsed/refractory multiple myeloma to see how well they work together.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions affecting various organs, infusion-related symptoms like fever or chills, fatigue, blood count changes that can increase infection risk, and possible allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have already tried at least 3 different treatments, including certain types of medications, or your disease did not respond to those medications.
Select...
You had a transplant of your own blood-forming stem cells more than 12 weeks ago.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately up to 4 years
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 That Experience Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort
Number of Participants That Experienced Drug Related Grade 3-4 AEs
Number of Participants That Experienced Drug Related Grade 3-4 SAEs
+7 moreSecondary outcome measures
AUC (0-T) in the Nivolumab + Daratumumab Cohort
AUC (TAU) in the Nivolumab + Daratumumab Cohort
Best Overall Response
+16 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Syncope
1%
Superior vena cava syndrome
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab
Trial Design
5Treatment groups
Experimental Treatment
Group I: Nivolumab monotherapy (Dose Escalation)Experimental Treatment1 Intervention
Nivolumab solution intravenously as specified
Non-randomized
Enrollment is closed for this cohort
Group II: Nivolumab + LirilumabExperimental Treatment2 Interventions
Non-randomized
Nivolumab: 3 mg/kg given every 2 weeks Lirilumab: 3 mg/kg given every 4 weeks
Enrollment is closed for this cohort
Group III: Nivolumab + IpilimumabExperimental Treatment2 Interventions
Nivolumab and Ipilimumab solution intravenously as specified
Non-randomized
Enrollment is closed for this cohort
Group IV: Nivo + Dara + Pom + Dexa vs. Nivo + DaraExperimental Treatment4 Interventions
Randomized
Nivolumab:
Cycle 1: 240 mg Day 15 Cycle 2-6: 240 mg Days 1, 15 Cycle 7 & beyond: 480 mg Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg Days 1, 15 Cycle 7 & beyond: 16 mg/kg Day 1
Pomalidomide:
4 mg po (by mouth) daily on Days 1 - 21 of each 28-day cycle
Dexamethasone:
Weeks without daratumumab dosing:
40 mg po daily (Days 1, 8, 15, 22) of each 28-day cycle for participants ≤ 75 years old
20 mg po daily (Days 1, 8, 15, 22) of each 28-day cycle for participants > 75 years old
Weeks with daratumumab dosing:
20 mg iv before the daratumumab infusion and 20 mg po after the daratumumab infusion in participants ≤ 75 years old
16 mg iv before the daratumumab infusion and 4 mg po after the daratumumab infusion in participants > 75 years old
Enrollment is closed for this cohort
Group V: Daratumumab vs. Nivolumab + DaratumumabExperimental Treatment2 Interventions
Randomized
Nivolumab:
Cycle 1: 240 mg Day 15 Cycle 2 & beyond: 480 mg Day 1
Daratumumab:
Cycle 1-2: 16 mg/kg Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg Days 1, 15 Cycle 7 & beyond: 16 mg/kg Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Pomalidomide
2011
Completed Phase 2
~1020
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2640
Lirilumab
2017
Completed Phase 2
~420
Daratumumab
2014
Completed Phase 3
~1860
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,629 Previous Clinical Trials
4,125,985 Total Patients Enrolled
84 Trials studying Multiple Myeloma
29,362 Patients Enrolled for Multiple Myeloma
Janssen, LPIndustry Sponsor
158 Previous Clinical Trials
304,642 Total Patients Enrolled
23 Trials studying Multiple Myeloma
8,886 Patients Enrolled for Multiple Myeloma
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab monotherapy (Dose Escalation)
- Group 2: Nivolumab + Ipilimumab
- Group 3: Nivolumab + Lirilumab
- Group 4: Nivo + Dara + Pom + Dexa vs. Nivo + Dara
- Group 5: Daratumumab vs. Nivolumab + 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.
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