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Monoclonal Antibodies
Durvalumab + Pomalidomide +/- Dexamethasone for Multiple Myeloma
Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have failed last line of treatment (refractory to last line of treatment)
Prior anti-myeloma treatments must have included a lenalidomide AND proteasome inhibitor alone or in combination
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 year
Awards & highlights
Study Summary
This trial is studying a combination of drugs as a possible treatment for multiple myeloma. A partial clinical hold has been placed on the trial by the FDA based on data related to risks of one of the drugs in the combination in patients with multiple myeloma.
Who is the study for?
This trial is for adults with active multiple myeloma who have tried at least two other treatments, including a lenalidomide and proteasome inhibitor, without success. They must not be pregnant or breastfeeding, free from certain severe health conditions like heart disease or uncontrolled infections, and cannot be current smokers or have had certain recent vaccinations.Check my eligibility
What is being tested?
The study aims to find the best dose and regimen of Durvalumab alone or combined with Pomalidomide and possibly Dexamethasone in those whose multiple myeloma has relapsed after previous treatments. It's an early-phase trial that was put on hold due to safety concerns but continues for those benefiting as per their doctor's judgment.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, blood disorders such as low counts leading to increased infection risk. Specific risks are associated with each drug: Durvalumab can cause organ inflammation; Pomalidomide may lead to blood clots; Dexamethasone could cause mood swings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My last cancer treatment did not work.
Select...
I have been treated with lenalidomide and a proteasome inhibitor for my myeloma.
Select...
I can take care of myself and perform daily activities.
Select...
I have been diagnosed with active multiple myeloma and it can be measured.
Select...
My myeloma was stable after treatment before it worsened.
Select...
I have received at least 2 different treatments for my myeloma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting Toxicities (DLTs)
Secondary outcome measures
Adverse Events (AEs)
Duration of response (DOR)
Overall response rate (ORR)
+7 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: Durvalumab monotherapyExperimental Treatment1 Intervention
Intravenous (IV) durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle
Group II: Durvalumab + pomalidomide (POM) + dexamethasone (dex)Experimental Treatment3 Interventions
IV durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle with Oral POM 4 mg/day on Days 1 to 21 of each 28-day treatment cycle and Oral dex 40 mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15, and 22 of a 28-day cycle
Group III: Durvalumab + pomalidomide (POM)Experimental Treatment2 Interventions
IV durvalumab at assigned dose level (750, 1500, 2250, or 3000 mg) over 1 hour on day 1 of a 28-day cycle and Oral POM 4 mg/day on Days 1 to 21 of each 28-day treatment cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
FDA approved
Durvalumab
FDA approved
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
CelgeneLead Sponsor
642 Previous Clinical Trials
130,439 Total Patients Enrolled
144 Trials studying Multiple Myeloma
41,985 Patients Enrolled for Multiple Myeloma
Lars Sternas, MD, PhDStudy DirectorCelgene Corporation
3 Previous Clinical Trials
719 Total Patients Enrolled
3 Trials studying Multiple Myeloma
719 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received treatment for myeloma less than 2 weeks ago.My last cancer treatment did not work.I have been treated with lenalidomide and a proteasome inhibitor for my myeloma.I have taken pomalidomide before and my disease did not improve.You have had a severe allergic reaction to thalidomide, lenalidomide, POM, or dex.I have moderate to severe numbness, tingling, or pain in my hands or feet.I've been cancer-free for over 5 years, except for certain skin or early-stage cancers.I can take care of myself and perform daily activities.I have a type of cancer called EMP that can be measured on scans and is possible to biopsy.My multiple myeloma does not produce high levels of M-protein.You are currently smoking cigarettes.I have not had a live vaccine in the last 30 days.I have a serious heart condition.I am not pregnant, nursing, breastfeeding, nor planning to become pregnant during the study.I have been diagnosed with active multiple myeloma and it can be measured.I have complications like blood clots or multiple myeloma affecting my brain or lungs.I have another cancer besides skin or treated cervical cancer that is getting worse or needs treatment.I have been treated with specific immune system targeting drugs before.I've been treated with a monoclonal antibody recently.I had a severe rash from thalidomide, lenalidomide, or pomalidomide.I am positive for HIV or hepatitis A, B, or C.I have had an organ or bone marrow transplant.My myeloma was stable after treatment before it worsened.I have received at least 2 different treatments for my myeloma.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab monotherapy
- Group 2: Durvalumab + pomalidomide (POM)
- Group 3: Durvalumab + pomalidomide (POM) + dexamethasone (dex)
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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