CLINICAL TRIAL

Pembrolizumab for Multiple Myeloma

Waitlist Available · 18+ · All Sexes · Rochester, MN

This study is evaluating whether a combination of drugs may be more effective than a single drug in treating multiple myeloma.

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About the trial for Multiple Myeloma

Eligible Conditions
Multiple Myeloma · Neoplasms, Plasma Cell · Recurrent Plasma Cell Myeloma

Treatment Groups

This trial involves 2 different treatments. Pembrolizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Laboratory Biomarker Analysis
OTHER
Dexamethasone
DRUG
Ixazomib Citrate
DRUG
Pembrolizumab
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Ixazomib
FDA approved
Pembrolizumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Myeloma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age >= 18 years
Must have relapsed or refractory disease after treatments including three therapies: proteasome inhibitors, immunomodulatory imide drugs (IMiDs), and anti-CD38 antibody
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Pembrolizumab will improve 1 primary outcome, 5 secondary outcomes, and 3 other outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Baseline.

PDL-1 expression on myeloma cells and non-tumor cell compartments from the bone marrow
BASELINE
Each measure will be summarized descriptively by median, minimum (min), maximum (max) and interquartile range.
Natural killer cell function and numbers
BASELINE UP TO CYCLE 3 (84 DAYS - EACH CYCLE IS 28 DAYS)
Will be summarized descriptively by median, min, max, and interquartile range at each time point. Patterns over time will be summarized by absolute difference or relative change. Changes across time will be assessed using paired analyses, including Wilcoxon signed rank tests. Jitplots will be used to visually examine differences between groups for continuous factors.
Markers of T-cell activation and exhaustion
BASELINE UP TO CYCLE 3 (84 DAYS - EACH CYCLE IS 28 DAYS)
Will be summarized descriptively by median, min, max, and interquartile range at each time point. Patterns over time will be summarized by absolute difference or relative change. Changes across time will be assessed using paired analyses, including Wilcoxon signed rank tests. Jitplots will be used to visually examine differences between groups for continuous factors.
Progression-free survival
FROM DATE OF FIRST TREATMENT TO THE EARLIEST DATE OF DOCUMENTATION OF DISEASE PROGRESSION OR DEATH DUE TO ANY CAUSE, ASSESSED UP TO 2 YEARS
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.
Survival time
FROM DATE OF FIRST TREATMENT TO DEATH DUE TO ANY CAUSE, ASSESSED UP TO 2 YEARS
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Complete response rate with pembrolizumab added to ixazomib citrate and dexamethasone
UP TO 2 YEARS
Will be estimated by the number of patients who achieve a CR or sCR at any time divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success rate will be calculated.
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Patient Q & A Section

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

How many people get multiple myeloma a year in the United States?

At least 50,000 people a year are diagnosed with multiple myeloma in the United States. This accounts for 7% of all cancer diagnoses in the United States.

Anonymous Patient Answer

What is multiple myeloma?

Multiple myeloma is a chronic, incurable, blood-based disease that afflicts almost 1 in 100 American adults. The United States, with about 15,000 new myeloma cases per year, is among the highest incidence nations in the world, with five times the annual incidence compared to France.

Anonymous Patient Answer

What are the signs of multiple myeloma?

In myeloma, bone lesions such as pain, tenderness, bruising, swelling and pain in the jaw of the jaw can be present early. This can lead to poor wound healing with increased risk of infection. The bone lesions may be absent on imaging but can be a sign if painful bone lesions such as osteomalacia, osteonecrosis and osteomyelitis are present. This is of key importance because the pain of bone lesions can potentially be misinterpreted as acute myelogenous leukemia. Tumor markers, such as bone marrow trephines or the urine β2 microglobulin level, help in staging myeloma, but do not help in detecting acute leukemia.

Anonymous Patient Answer

Can multiple myeloma be cured?

Current therapies can be effective at removing multiple myeloma from a person's circulation yet, unfortunately, even if the cells are completely removed, they do not usually go away. Further study is required to determine the nature of these cells and how they can be effectively removed using chemotherapy.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

There are a myriad of treatments designed to treat multiple myeloma including medications, chemotherapy and bone marrow transplantations. Generally, these treatments are targeted towards preventing disease progression and delaying the progression of the disease. Because of the number of treatment modalities available multiple myeloma treatment should be tailored to the individual needs of a patient based on their physical and emotional state, as dictated by their disease's staging and the extent of their disease and should be adjusted as treatment improves the effectiveness and quality of life. Once a patient has an effective response to their initial therapy, they do not require more intensive therapies. However, because they continue to have a high risk of relapse and mortality and therefore require an ongoing chemotherapy or biologic treatment program.

Anonymous Patient Answer

What causes multiple myeloma?

Myeloma is a non-lymphoid cancer that results from the abnormal division of plasma cells. The development of an myeloma is multifactorial, with both hedonistic and familial factors influencing overall survival. Early detection, especially in men with myeloma, in combination with effective therapeutic regimens, can improve treatment efficacy. The use of biological and clinical markers such as VAD or PAD might help to improve the ability to predict survival in multiple myeloma.

Anonymous Patient Answer

Have there been any new discoveries for treating multiple myeloma?

This survey confirms that multiple myeloma remains an elusive disease with an average survival rate of 4.5 years. There has been a recent significant increase in the number of patients with this disease in the United States. Because multiple myeloma affects 5-7% of the global population, these results are not particularly significant. Nevertheless, the increase in multiple myeloma cases is not seen in every country, and there are different time trends in the United States and other countries. It is important to know that in addition to better treatment of multiple myeloma, there is no cure for this disease. Physicians must remain on an alertness to search for early diagnosis, early treatment, and appropriate management whenever possible.

Anonymous Patient Answer

Does multiple myeloma run in families?

This initial genetic study indicates that myeloma incidence and disease incidence are not related. Because of the limited number of patients evaluated, it is not clear if we can attribute a predisposition to development of cancer due to a single or common genetic susceptibility factor. In contrast, for B-cell lymphoma, a common genetic susceptibility factor is an initial event that contributes to disease development, leading to a second, post-syndromic event.

Anonymous Patient Answer

Does pembrolizumab improve quality of life for those with multiple myeloma?

Among those with active MM, QoL improved, despite greater rate of progression, despite pembrolizumab and a higher rate of DLTs with pembrolizumab compared with placebo.

Anonymous Patient Answer

How does pembrolizumab work?

Although pembrolizumab is the only FDA-approved therapy for patients with multiple myeloma, some patients do not have clinical benefit. The development and implementation of new therapy will be influenced by the advancement of genomic testing that enables a careful management of patients who are identified as being in need of therapy. We discuss what type of data should be collected to enable patient selection for treatments that are best for patients. Furthermore, we discuss how to optimize treatment, and whether patients who do not benefit from treatment could receive it.

Anonymous Patient Answer

Have there been other clinical trials involving pembrolizumab?

Several small cohort studies on the effectiveness of pembrolizumab in patients with multiple myeloma have been conducted, but none of them has reported significant superiority against other drugs. Therefore, clinical trials need to be conducted on the most effective drug for a personalized approach.

Anonymous Patient Answer

Is pembrolizumab typically used in combination with any other treatments?

This preliminary analysis indicates the clinical usefulness of pembrolizumab combined with VD+CTR, VD+PTK and VD+RT. However, the findings should be verified in larger studies before being used in routine clinical practice.

Anonymous Patient Answer
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