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Elo-Pom-Dex for Multiple Myeloma
Phase 2
Waitlist Available
Led By Ravi Vij, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of multiple myeloma
Received 2 to 6 cycles of induction therapy per standard of care prior to 2nd autologous stem cell transplantation
Must not have
Known hypersensitivity to pomalidomide, dexamethasone, or any excipients in elotuzumab, formulation, or recombinant protein
History of plasma cell leukemia or MM central nervous system (CNS) involvement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post completion of treatment
Awards & highlights
All Individual Drugs Already Approved
Approved for 60 Other Conditions
No Placebo-Only Group
Summary
This trial is testing a new combination of drugs to see if it can help people with multiple myeloma who have had two stem cell transplants.
Who is the study for?
This trial is for adults aged 18-75 with relapsed multiple myeloma after a first stem cell transplant. They must have failed 1 or 2 treatment lines, received specific induction therapy before a second transplant, and be responding to current treatment. Participants need proper organ function and can't join if they're pregnant, breastfeeding, have severe neuropathy, other active cancers or infections, heart issues, uncontrolled illnesses or are sensitive to the drugs tested.
What is being tested?
The study tests whether adding Elotuzumab (a monoclonal antibody) to Pomalidomide (an immunomodulatory drug) and Dexamethasone (a steroid), known as Elo-Pom-Dex regimen, improves outcomes in patients receiving their second autologous stem cell transplantation for multiple myeloma.
What are the potential side effects?
Possible side effects include immune system effects like increased risk of infection; blood clots; fatigue; bone marrow suppression leading to low blood counts; allergic reactions; nerve damage causing numbness or pain; digestive issues such as constipation or diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma through a tissue test.
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I've had 2-6 rounds of initial treatment before my second stem cell transplant.
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My blood tests and organ functions are within normal ranges.
Select...
My multiple myeloma relapsed after first-line stem cell transplant treatment.
Select...
I have tried 1 or 2 treatments for my multiple myeloma without success.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am between 18 and 75 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am allergic to pomalidomide, dexamethasone, or components in elotuzumab.
Select...
I have had plasma cell leukemia or myeloma in my brain or spinal cord.
Select...
I am being treated for another cancer besides the one being studied.
Select...
I have severe nerve pain or numbness.
Select...
I am on dialysis.
Select...
I do not have any uncontrolled illnesses like heart problems or infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post completion of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post completion of treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Event-free Survival (EFS) Rate
Secondary study objectives
Complete Response Rate (CRR)
Overall Response Rate (ORR)
Overall Survival (OS)
+2 moreSide effects data
From 2015 Phase 2 trial • 36 Patients • NCT0201111372%
NEUTROPENIA
47%
ANAEMIA
44%
THROMBOCYTOPENIA
25%
NASOPHARYNGITIS
25%
PYREXIA
25%
CONSTIPATION
22%
LYMPHOPENIA
19%
DIARRHOEA
19%
OEDEMA PERIPHERAL
19%
NAUSEA
19%
RASH
17%
LEUKOPENIA
17%
INSOMNIA
17%
MALAISE
14%
PNEUMONIA
14%
DYSGEUSIA
11%
FATIGUE
11%
EPISTAXIS
11%
DECREASED APPETITE
11%
HYPERURICAEMIA
11%
HYPOALBUMINAEMIA
11%
UPPER RESPIRATORY TRACT INFECTION
11%
HYPOKALAEMIA
8%
RASH MACULO-PAPULAR
8%
Pharyngitis
8%
HYPERGLYCAEMIA
8%
HYPOPHOSPHATAEMIA
8%
HYPOXIA
8%
ANXIETY
8%
MYALGIA
8%
HEPATIC FUNCTION ABNORMAL
8%
HERPES ZOSTER
6%
CANCER PAIN
6%
DECUBITUS ULCER
6%
PERIPHERAL SENSORY NEUROPATHY
6%
INCREASED APPETITE
6%
CYSTITIS
6%
DIABETES MELLITUS
6%
GASTROENTERITIS
6%
RESTLESSNESS
6%
HEADACHE
6%
NEUROPATHY PERIPHERAL
6%
WEIGHT INCREASED
6%
HYPOTENSION
6%
HYPOGAMMAGLOBULINAEMIA
6%
ABDOMINAL PAIN UPPER
6%
HAEMORRHOIDS
6%
ASTHMA
6%
VOMITING
6%
BRONCHITIS
6%
HYPERCALCAEMIA
6%
HYPOCALCAEMIA
6%
HYPONATRAEMIA
6%
HYPERSOMNIA
6%
DYSPHONIA
6%
PLEURAL EFFUSION
6%
HICCUPS
6%
ALANINE AMINOTRANSFERASE INCREASED
6%
ASPARTATE AMINOTRANSFERASE INCREASED
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
MUSCLE SPASMS
6%
WEIGHT DECREASED
6%
TREMOR
6%
HYPOTHYROIDISM
6%
SOMNOLENCE
6%
PROCTALGIA
6%
DYSPNOEA
3%
PNEUMONIA PNEUMOCOCCAL
3%
MULTI-ORGAN FAILURE
3%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
SEPSIS
3%
INTERSTITIAL LUNG DISEASE
3%
C-REACTIVE PROTEIN INCREASED
3%
CARDIAC FAILURE
3%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
3%
URINARY RETENTION
3%
MENINGITIS
3%
SPINAL COMPRESSION FRACTURE
3%
BLOOD FIBRINOGEN DECREASED
3%
BACK PAIN
3%
SHOCK HAEMORRHAGIC
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pomalidomide Plus Dexamethasone
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
1Treatment groups
Experimental Treatment
Group I: Elotuzumab + Pomalidomide + DexamethasoneExperimental Treatment3 Interventions
* Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study.
* Following induction, patients will undergo standard of care ASCT melphalan conditioning (ASCT). Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol.
* Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT:
* 10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+
* 2 mg pomalidomide daily on Days 1-21 of all cycles
* 40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+
* Continuation therapy may continue until relapse or progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elotuzumab
FDA approved
Pomalidomide
FDA approved
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,991 Previous Clinical Trials
2,295,859 Total Patients Enrolled
37 Trials studying Multiple Myeloma
2,232 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,522 Total Patients Enrolled
90 Trials studying Multiple Myeloma
22,408 Patients Enrolled for Multiple Myeloma
CelgeneIndustry Sponsor
645 Previous Clinical Trials
130,407 Total Patients Enrolled
146 Trials studying Multiple Myeloma
41,781 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition worsened on elotuzumab/pomalidomide or within 2 months after stopping it.I am allergic to pomalidomide, dexamethasone, or components in elotuzumab.I have had more than one organ or bone marrow transplant before joining this study.I have had plasma cell leukemia or myeloma in my brain or spinal cord.I am being treated for another cancer besides the one being studied.You have HIV or active hepatitis A, B, or C. You don't need to take an antibody test for screening.I have been diagnosed with multiple myeloma through a tissue test.I have severe nerve pain or numbness.I am on dialysis.I am not pregnant or breastfeeding and have had two negative pregnancy tests before starting pomalidomide.I've had 2-6 rounds of initial treatment before my second stem cell transplant.My blood tests and organ functions are within normal ranges.My multiple myeloma relapsed after first-line stem cell transplant treatment.I've had a second stem cell transplant with melphalan and am responding well 80-120 days post-transplant.I am between 18 and 75 years old.I can take care of myself and am up and about more than half of my waking hours.I agree to follow the pregnancy testing schedule required by the POMALYST REMS® program.I have tried 1 or 2 treatments for my multiple myeloma without success.I do not have any uncontrolled illnesses like heart problems or infections.
Research Study Groups:
This trial has the following groups:- Group 1: Elotuzumab + Pomalidomide + Dexamethasone
Awards:
This trial has 3 awards, including:- 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.
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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