← Back to Search

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

Must not have

Has received previous therapy with pomalidomide and did not achieve at least a stable disease

Has non-secretory or oligosecretory multiple myeloma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 year

Awards & highlights

All Individual Drugs Already Approved

Approved for 60 Other Conditions

No Placebo-Only Group

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.

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.

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 below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have taken pomalidomide before and my disease did not improve.

Select...

My multiple myeloma does not produce high levels of M-protein.

Select...

I have not had a live vaccine in the last 30 days.

Select...

I have a serious heart condition.

Select...

I have complications like blood clots or multiple myeloma affecting my brain or lungs.

Select...

I have been treated with specific immune system targeting drugs before.

Select...

I've been treated with a monoclonal antibody recently.

Select...

I had a severe rash from thalidomide, lenalidomide, or pomalidomide.

Select...

I have had an organ or bone marrow transplant.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting Toxicities (DLTs)

Secondary study objectives

Adverse Events (AEs)

Duration of response (DOR)

Overall response rate (ORR)

+7 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Anorexia

30%

Constipation

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 15Eligibility criteria met