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Proteasome Inhibitor
Bortezomib + Pembrolizumab +/- Pelareorep for Multiple Myeloma
Phase 1 & 2
Recruiting
Led By Kevin R Kelly, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of MM with measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing the safety of a combination of drugs to treat patients with multiple myeloma that has come back or does not respond to treatment.
Who is the study for?
Adults over 18 with relapsed or refractory multiple myeloma, who've had at least three prior treatments, can join this trial. They should be in good physical condition (ECOG 0-1), have normal thyroid and adrenal hormone levels, and a life expectancy of more than 3 months. People with HIV, active autoimmune diseases requiring recent treatment, certain infections or vaccinations, severe allergies to study drugs' ingredients, CNS metastases, another progressing cancer within the last five years or significant heart issues cannot participate.Check my eligibility
What is being tested?
The AMBUSH trial is testing how safe and effective it is to combine bortezomib and dexamethasone (chemotherapy) with pembrolizumab (an immunotherapy antibody) either with or without pelareorep (a modified virus). The goal is to see if these combinations are better for treating patients whose multiple myeloma has returned after previous treatments or isn't responding anymore.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs due to pembrolizumab; nerve damage from bortezomib; infection risks from pelareorep; fatigue; hormonal imbalances; blood disorders from chemotherapy agents like dexamethasone; as well as general inflammation throughout the body.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My multiple myeloma is confirmed and measurable.
Select...
I am fully active or can carry out light work.
Select...
My multiple myeloma has returned or didn't respond after 3 treatments.
Select...
I don't have ongoing side effects from past cancer treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of adverse events (AEs) (Phase 1B)
Incidence of dose-limiting toxicities (DLTs) (Phase 1B)
Heart rate
Secondary outcome measures
Duration of response (DOR) (Phase 2)
Incidence of adverse events (Phase 2)
ORR (CR + PR) (Phase 1B)
+3 moreOther outcome measures
CD4 and CD8 T-cell reactivity (Phase 1B, Phase 2)
Changes in gene expression (Phase 1B, Phase 2)
Changes in the T cell repertoire within peripheral blood and the TME (Phase 1B, Phase 2)
+3 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort II (standard therapy, pelareorep)Experimental Treatment4 Interventions
Patients receive bortezomib SC or IV and dexamethasone either PO, IV, or IM on days 1, 8, and 15 of each cycle. Patients also receive pelareorep IV over 60 minutes on days 1, 2, 8, 9, 15, and 16 and pembrolizumab IV over 30 minutes on day 9 of each cycle. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Cohort I (standard therapy)Experimental Treatment3 Interventions
Patients receive bortezomib SC) or IV and dexamethasone PO, IV, or IM on days 1, 8, and 15 of each cycle. Patients also receive pembrolizumab IV over 30 minutes on day 9 of each cycle. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
2005
Completed Phase 2
~1140
Dexamethasone
2007
Completed Phase 4
~2590
Pelareorep
2010
Completed Phase 2
~150
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,812 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,089 Patients Enrolled for Multiple Myeloma
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,246 Total Patients Enrolled
3 Trials studying Multiple Myeloma
127 Patients Enrolled for Multiple Myeloma
Kevin R Kelly, MDPrincipal InvestigatorUniversity of Southern California
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart condition.You have had a severe allergic reaction to certain substances in the past.I have or had lung inflammation that needed steroids.I have an active tuberculosis infection.I am fully active or can carry out light work.I had radiotherapy less than 2 weeks before starting the study treatment.I do not have any severe medical or psychiatric conditions.I have an autoimmune disease treated with medication in the last 2 years.I have dementia or changes in my mental status.I have not received a live vaccine in the last 30 days.I have active brain metastases or carcinomatous meningitis.I am currently on medication for an infection.You have known mental health or drug problems.I experience significant numbness or pain in my hands or feet.Your thyroid and adrenal hormones are at normal levels.I have received an organ or tissue transplant from another person.I have had a stem cell transplant from a donor.My multiple myeloma is confirmed and measurable.I have another cancer that has gotten worse or needed treatment in the last 5 years.I have an immune system disorder or I'm on long-term steroids.I don't have any health issues that could affect the study's results.Your blood and body chemistry must meet certain standards.My multiple myeloma has returned or didn't respond after 3 treatments.You have been diagnosed with Hepatitis B or C.You have a severe allergic reaction to pembrolizumab or any of its ingredients.I don't have ongoing side effects from past cancer treatments.I am 18 years old or older.I have been diagnosed with HIV.You have a positive pregnancy test within 72 hours before the study starts.You are expected to live for at least 3 more months.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.I have received treatment with specific medications before.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort I (standard therapy)
- Group 2: Cohort II (standard therapy, pelareorep)
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are actively involved in this trial?
"Confirmed. Information located on clinicaltrials.gov affirms that recruitment for this medical investigation is currently underway; the first post was made on October 7th 2022 and recently revised on November 12th of the same year. The research team seeks to enlist 42 volunteers at two separate sites."
Answered by AI
Is this research endeavor currently enrolling participants?
"According to clinicaltrials.gov, this experiment is soliciting participants at the present time. It was advertised on October 7th 2022 and has seen its protocols most recently modified in November 12th of the same year."
Answered by AI
What are the expected outcomes of this clinical experiment?
"Over the course of up to three years, this clinical trial will measure the incidence of dose-limiting toxicities as its primary outcome. Additionally, researchers must consider ORR (CR + PR) per IMWG Uniform Response Criteria for MM and duration/progression-free survival in order to draw comprehensive conclusions from their data collection efforts."
Answered by AI
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