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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post completion of treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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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.
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My multiple myeloma relapsed after first-line stem cell transplant treatment.
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I have tried 1 or 2 treatments for my multiple myeloma without success.
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I can take care of myself and am up and about more than half of my waking hours.
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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post completion of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post completion of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free Survival (EFS) Rate
Secondary outcome measures
Complete Response Rate (CRR)
Overall Response Rate (ORR)
Overall Survival (OS)
+2 more

Side effects data

From 2015 Phase 2 trial • 36 Patients • NCT02011113
72%
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%
EPISTAXIS
11%
FATIGUE
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%
WEIGHT INCREASED
6%
DECUBITUS ULCER
6%
CANCER PAIN
6%
DIABETES MELLITUS
6%
CYSTITIS
6%
GASTROENTERITIS
6%
PERIPHERAL SENSORY NEUROPATHY
6%
HEADACHE
6%
NEUROPATHY PERIPHERAL
6%
INCREASED APPETITE
6%
RESTLESSNESS
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%
PNEUMOCYSTIS JIROVECII PNEUMONIA
3%
SEPSIS
3%
PNEUMONIA PNEUMOCOCCAL
3%
MULTI-ORGAN FAILURE
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

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?

CelgeneIndustry Sponsor
633 Previous Clinical Trials
128,017 Total Patients Enrolled
142 Trials studying Multiple Myeloma
40,838 Patients Enrolled for Multiple Myeloma
Washington University School of MedicineLead Sponsor
1,930 Previous Clinical Trials
2,298,960 Total Patients Enrolled
31 Trials studying Multiple Myeloma
2,192 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,635 Previous Clinical Trials
4,126,854 Total Patients Enrolled
86 Trials studying Multiple Myeloma
29,845 Patients Enrolled for Multiple Myeloma

Media Library

Pomalidomide Clinical Trial Eligibility Overview. Trial Name: NCT03030261 — Phase 2
Multiple Myeloma Research Study Groups: Elotuzumab + Pomalidomide + Dexamethasone
Multiple Myeloma Clinical Trial 2023: Pomalidomide Highlights & Side Effects. Trial Name: NCT03030261 — Phase 2
Pomalidomide 2023 Treatment Timeline for Medical Study. Trial Name: NCT03030261 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any significant risks associated with Pomalidomide?

"While Pomalidomide has not been proven effective in clinical trials, there is evidence that it is safe. Our team at Power rates the safety of this medication as a 2."

Answered by AI

Are there any other continents where this research is being conducted?

"Currently, there are 4 centres actively recruiting for this trial. These include Washington University School of Medicine in Saint Louis, University Health Network - Princess Margaret Cancer Centre in Toronto, and Colorado Blood Cancer Institute (Sarah Cannon) in Denver."

Answered by AI

What are the chief medical benefits of Pomalidomide?

"Pomalidomide is a medication typically used to treat ophthalmia and sympathetic. However, it has also been shown to be effective in managing branch retinal vein occlusion, macular edema, and other eye-related conditions."

Answered by AI

Is this the first time Pomalidomide has been used in a clinical setting?

"The first clinical trials for pomalidomide were conducted in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. To date, there have been 1138 completed global clinical trials. Right now, 603 are actively recruiting patients with a large number of these taking place in Saint Louis, Missouri."

Answered by AI

Are we still able to include new participants in this research?

"According to the most recent update on clinicaltrials.gov, this study is not currently looking for patients. This trial was first posted on November 22nd, 2017 and was last edited on October 17th, 2020. Although this specific study isn't searching for volunteers at the moment, there are 1,430 other trials which are still enrolling participants."

Answered by AI

Is this study accessible to people who are younger than 55 years old?

"According to the eligibility criteria hosted on this site, eligible applicants are between 18-75 years old. There are 115 studies currently available for patients under 18 and 1,341 studies open to people over 65."

Answered by AI

Could I potentially participate in this research project?

"This clinical trial is looking for 25 people who have multiple myeloma and meet the following criteria: - Histologically confirmed diagnosis of multiple myeloma- Received prior autologous stem cell transplantation as first line therapy for multiple myeloma with subsequent disease relapse/progression- Failed 1 or 2 lines of treatment for multiple myeloma. A line of treatment includes all therapy including induction, transplant, and maintenance administered in a sequence in the absence of relapse/progression. Once relapse/progression occurs and subsequently the anti-myeloma treatment is changed, a new line of treatment has begun"

Answered by AI

How many individuals are being treated with this medication?

"This trial is not recruiting patients at the moment, as seen by the last update on the study being from over a year ago. 827 other clinical trials for multiple myeloma and 603 trials for Pomalidomide are currently enrolling patients if you're interested in exploring more treatment options."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma
2017. "Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03030261.
~3 spots leftby Apr 2025
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