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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

Be older than 18 years old

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately up to 4 years for reporting.

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 more

Secondary outcome measures

AUC (0-T) in the Nivolumab + Daratumumab Cohort

AUC (TAU) in the Nivolumab + Daratumumab Cohort

Best Overall Response

+16 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533

57%

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%

Pyrexia

21%

Neutropenia

19%

Headache

19%

Hypomagnesaemia

18%

Arthralgia

16%

Asthenia

16%

Dizziness

16%

Neutrophil count decreased

15%

Thrombocytopenia

15%

Insomnia

14%

Hyponatraemia

14%

Rash

14%

Weight decreased

14%

Platelet count decreased

13%

Blood creatinine increased

13%

White blood cell count decreased

12%

Hypokalaemia

12%

Pruritus

12%

Abdominal pain

12%

Pain in extremity

11%

Myalgia

11%

Alanine aminotransferase increased

11%

Aspartate aminotransferase increased

10%

Alopecia

10%

Dry skin

10%

Hypoalbuminaemia

10%

Muscular weakness

10%

Chest pain

10%

Dysgeusia

10%

Pneumonia

10%

Productive cough

Abdominal pain upper

Upper respiratory tract infection

Hypothyroidism

Mucosal inflammation

Peripheral sensory neuropathy

Lacrimation increased

Nasopharyngitis

Non-cardiac chest pain

Epistaxis

Haemoptysis

Stomatitis

Dysphonia

Hypertension

Bronchitis

Dehydration

Hyperkalaemia

Chills

Blood alkaline phosphatase increased

Hyperglycaemia

Lymphocyte count decreased

Anxiety

Hypophosphataemia

Leukopenia

Pleural effusion

Neuropathy peripheral

Pneumonitis

Oropharyngeal pain

Rash maculo-papular

Hypotension

Malaise

Pain

Musculoskeletal chest pain

Dry mouth

Urinary tract infection

Dyspepsia

Gamma-glutamyltransferase increased

Depression

Muscle spasms

Fall

Pulmonary embolism

Metastases to central nervous system

Myocardial infarction

Febrile neutropenia

Musculoskeletal pain

Chronic obstructive pulmonary disease

Sepsis

Malignant pleural effusion

General physical health deterioration

Adrenal insufficiency

Atrial fibrillation

Cardiac failure

Embolism

Small intestinal haemorrhage

Cancer pain

Neoplasm progression

Pneumothorax

Atrial flutter

Bone pain

Circulatory collapse

Confusional state

Pericardial effusion malignant

Syncope

Hypercalcaemia

Femur fracture

Superior vena cava syndrome

Bronchial obstruction

Performance status decreased

Pancytopenia

Colitis

Pericardial effusion

Gastrointestinal haemorrhage

Ileus

Small intestinal obstruction

Lung cancer metastatic

Respiratory tract infection

Respiratory failure

Tumour pain

Appendicitis

Skin infection

Ataxia

Seizure

100%

80%

60%

40%

20%

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