CLINICAL TRIAL

Selinexor for Multiple Myeloma

Recruiting · 18+ · All Sexes · Fort Worth, TX

Study of Selinexor Plus DRd for Newly Diagnosed Multiple Myeloma

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About the trial for Multiple Myeloma

Eligible Conditions
Plasma Cell Myeloma · Kahler Disease · Multiple Myeloma · Multiple Myeloma (MM) · Neoplasms, Plasma Cell

Treatment Groups

This trial involves 2 different treatments. Selinexor 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.
Lenalidomide
DRUG
Selinexor
DRUG
Dexamethasone Oral
DRUG
Daratumumab
DRUG
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
Lenalidomide
FDA approved
Selinexor
FDA approved
Daratumumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Multiple Myeloma or one of the other 4 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:
At least 18 years of age.
ii. Involved: uninvolved serum free light chains (FLC) ratio*** >100
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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: 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 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 Selinexor will improve 3 primary outcomes and 6 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of 6 months.

Stringent Complete Response Rate (sCR)
6 MONTHS
percentage of patients who had stringent complete response. Patients with a stringent complete response in addition to the criteria that is required to have a complete response are required to have a normal free light chain ratio in the serum and absence of clonal cells in the bone marrow determined by either immunofluorescence or immunohistochemistry.
Complete Response Rate (CR)
6 MONTHS
percentage of patients who had complete response. Complete response is when patients achieve a negative immunofixation on the serum and urine and who also have an appearance of a soft tissue plasmacytomas and achieve less than or equal to 5 percent (%) plasma cells in the bone marrow.
Objective Response Rate (ORR)
3 YEARS
percentage of patients who had either CR or sCR or very good partial response (VGPR) or partial response (PR).
Duration of Response
3 YEARS
the median time from first documented evidence of PR, CR,or sCR to date of progression or death or last date of contact for patients who did not progress or die
Minimal Residual Disease (MRD)
3 YEARS
number of patients who had CR or sCR and had: absence of phenotypically abnormal clonal plasma cells from bone marrow aspirates using Adaptive Technologies NGS Platform
Progression-Free Survival (PFS)
3 YEARS
the median time from randomization until the date of disease progression or death (by any cause in the absence of progression), regardless of whether the subject withdraws from the assigned study treatment
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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.

What causes multiple myeloma?

Multiple myeloma can result when antibody-producing plasma cells, the type of lymphocyte that normally produce the antibodies, are overproduced but fail to leave the bone marrow. Multiple myelomagenesis is not only an immunological phenomenon. Other nonimmunological causes have been suggested over recently. The pathogenetic mechanism of multiple myeloma may include a clone of myeloma cells that escapes deletion by the regulatory mechanisms of the bone marrow.

Anonymous Patient Answer

Can multiple myeloma be cured?

With good control of disease, some patients may be free of disease over 5 years, while others are still suffering relapsed disease. Current disease-modifying concepts in MM do not allow for a cure.

Anonymous Patient Answer

What are the signs of multiple myeloma?

The main symptoms include, bone pain, decreased appetite, low body weight, nausea and poor energy level. If an individual exhibits these symptoms for more than 3 months, it recommends that patient be referred to the medical team.\n\nThe clinical manifestations of disease are as follows:\n\n- Hematopoetic disease is mainly caused by the presence of malignant cells that invade any part of the blood.

Anonymous Patient Answer

What is multiple myeloma?

Around 80% of cases of MMC show one or more of the following symptoms: tiredness, weight loss, anemia, skeletal pain, fever, night sweats, and/or itchiness. Bone marrow biopsy is necessary to definitively diagnose this disorder.\n

Anonymous Patient Answer

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

The number of new diagnoses of multiple myeloma a year in the United States is expected to increase at a rate of 8% over 4 years. It is important to understand this new trend and implement the needs of the newly diagnosed patient population.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

Overall survival is low for patients with [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma). Most multiple myeloma is treated with systemic administration of high-dose bortezomib with or without dexamethasone. Novel agents were being studied in clinical trials for high-risk myeloma in the second and third decade of the 21st century. Patients treated with a combination of high-dose therapy and autologous stem cell transplantation have significant improvements in survival. There is ongoing trial for high-dose bortezomib-based regimes in patients with multiple myeloma.

Anonymous Patient Answer

What are the chances of developing multiple myeloma?

Overall, this study concluded that even though the risk of developing multiple myeloma is higher for the frail elderly, it is extremely difficult to determine accurately the individual risk of developing multiple myeloma based only on general health status. Although the elderly are at the highest risk of multiple myeloma, they need to be evaluated individually to make a more effective treatment plan tailored to their specific risks and needs.

Anonymous Patient Answer

How does selinexor work?

[For more information on selinexor, see (S-7010), a new drug in clinical trials that prevents the proliferation of cancer cells with the same translocation as found in multiple myeloma.] One study suggests that selinexor is more effective than the current standard, Velcade (Bortezomib). Velcade binds to the catalytic domain of a ubiquitin ligase (c-E3) which marks proteins that are to be degraded. It is this mark that in the future may lead to selinexor's toxicity. Multiple myeloma is a disease in which the proteasome is abnormally active.

Anonymous Patient Answer

What are the common side effects of selinexor?

Among the most commonly reported side effects in patients treated with selinexor are thrombocytopenia, diarrhea, nausea and vomiting, gastrointestinal hemorrhage, rash, headache, hyperlipidemia and hepatitis. Findings from a recent study also found that the magnitude of these events increases over time according to the number of cycles of treatment. The incidence of most side effects is lower for patients in a subset of these trials with more myalgias. Selinexor was efficacious in the first-line setting in our study and seems to be generally well tolerated in this patient population with relapsed and/or refractory disease.

Anonymous Patient Answer

What does selinexor usually treat?

Current and past clinical trials as well as the prescribing information describe selinexor as a treatment for multiple myeloma. Further studies are needed to evaluate selinexor in multiple myeloma to determine whether the benefit detected at FDA approval persists when patients are taken off treatment, as happens with other agents of this class.

Anonymous Patient Answer

How serious can multiple myeloma be?

The seriousness of MM may vary greatly at presentation, especially in myeloma patients<40 years old. The most important factor in the management of MM is careful treatment compliance.

Anonymous Patient Answer

What is selinexor?

Selirexor was effective as a single agent and combined with bortezomib in relapsed/refractory multiple myeloma. Selirexor can be an effective treatment option for patients with multiple myeloma.

Anonymous Patient Answer
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