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Monoclonal Antibodies
Durvalumab for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Research Sponsored by Celgene
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 pre-dose samples on day 1 of cycles 1, 2, 4, 6, 10, and 14 (study days 1, 29, 85, 141, 253, 393)
Awards & highlights
Study Summary
This study is evaluating whether a combination of drugs can improve the survival of people with multiple myeloma.
Eligible Conditions
- Multiple Myeloma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose samples on day 1 of cycles 1, 2, 4, 6, 10, and 14 (study days 1, 29, 85, 141, 253, 393)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose samples on day 1 of cycles 1, 2, 4, 6, 10, and 14 (study days 1, 29, 85, 141, 253, 393)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Participants With Dose-Limiting Toxicities (DLTs) During the Dose-Determining Timeframe (Day 1 - Day 28)
Secondary outcome measures
Durvalumab (DURVA) Serum PK Parameters in Cycle 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
Durvalumab (DURVA) Serum PK Parameters in Cycle 1: Clearance (CL)
Durvalumab (DURVA) Serum PK Parameters in Cycle 1: Maximum Observed Concentration (Cmax)
+22 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort C: High risk, Post-transplantExperimental Treatment2 Interventions
High risk, post-transplant NDMM participants were administered the following as maintenance therapy:
Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle
Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle
Group II: Cohort B: >=65 years old, TNEExperimental Treatment3 Interventions
>= 65 years old, transplant non-eligible [TNE], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered
Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle
Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance [CrCl]) value on Days 1 to 21 of each 28-day treatment cycle
Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles
Group III: Cohort A: High risk, TNEExperimental Treatment3 Interventions
High risk, transplant non-eligible [TNE], newly diagnosed multiple myeloma (NDMM) participants who were administered
Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle
Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance [CrCl]) value on Days 1 to 21 of each 28-day treatment cycle
Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Dexamethasone
2007
Completed Phase 4
~2590
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
636 Previous Clinical Trials
128,915 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,807 Patients Enrolled for Multiple Myeloma
Lars Sternas, MDStudy DirectorCelgene
1 Previous Clinical Trials
25 Total Patients Enrolled
1 Trials studying Multiple Myeloma
25 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,506 Previous Clinical Trials
3,369,474 Total Patients Enrolled
72 Trials studying Multiple Myeloma
25,231 Patients Enrolled for Multiple Myeloma
Frequently Asked Questions
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