CLINICAL TRIAL

Daratumumab for Multiple Myeloma

Recruiting · 18+ · All Sexes · Aurora, CO

This study is evaluating whether a drug called selinexor can be used to treat multiple myeloma.

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About the trial for Multiple Myeloma

Eligible Conditions
Multiple Myeloma in Relapse · Multiple Myeloma · Neoplasms, Plasma Cell

Treatment Groups

This trial involves 3 different treatments. Daratumumab is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Selinexor
DRUG
+
Daratumumab
DRUG
+
Dexamethasone
DRUG
Experimental Group 2
Carfilzomib
DRUG
+
Selinexor
DRUG
+
Dexamethasone
DRUG
Experimental Group 3
Pomalidomide
DRUG
+
Selinexor
DRUG
+
Dexamethasone
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
FDA approved
Pomalidomide
FDA approved
Selinexor
FDA approved
Daratumumab
FDA approved
Dexamethasone
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:
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of ≤ 2
Documented evidence of PD after achieving at least SD for ≥ 1 cycle during a previous MM regimen (i.e., relapsed MM)
If no measurable disease by serum or urine, then the presence of a plasmacytoma of ≥2cm in one dimension prior to start of study can be used to follow response via radiologic imaging.
Age ≥ 18 years
≤ 25% response (i.e, patient never achieved ≥ MR) or PD during or within 60 days from end of the most recent MM regimen (i.e., refractory MM)
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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: 2 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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 Daratumumab will improve 1 primary outcome, 6 secondary outcomes, and 3 other outcomes in patients with Multiple Myeloma. Measurement will happen over the course of 2 years.

Evaluation of My-DST related predictors of response
2 YEARS
ORR in patients with concordance or discordance between My-DST results and physicians selected regimen
Feasibility of My-DST testing to inform treatment choice
2 YEARS
Rate of identification of preferred partner therapy or combination
Reliability of My-DST testing to inform treatment choice
2 YEARS
Rate of assay failure
Safety and tolerability of selinexor
2 YEARS
To evaluate safety and tolerability of selinexor in combination with partner backbone agents using occurrence, nature and severity of Adverse Events
Duration of Response
2 YEARS
To evaluate the duration of response achieved with physician's choice selinexor-based combination therapy
Overall Survival
2 YEARS
To evaluate the duration of overall survival achieved with physician's choice selinexor-based combination therapy
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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.

Have there been any new discoveries for treating multiple myeloma?

There have not been any significant advances in MM treatment over the last 5 years. Clinical trials targeting proteasome inhibitors in combination with anthracyclines are ongoing. Targeting T-cell activating ligands such as CD40L has potential, but additional studies are needed. Monoclonal antibodies targeting cell adhesion molecules such as VCAM-1 or ICAM-1 may be beneficial in MM patients who are refractory to conventional chemotherapy. Further study of monoclonal antibodies directed against VCAM-1 and ICAM-1 will be important in this area. Gene therapy is being investigated in MM. The evaluation of immunotherapeutic agents and vaccines is underway.

Anonymous Patient Answer

What causes multiple myeloma?

We found that diabetes mellitus, thyroid disorders, and alcoholism were associated with an increased risk of MM. The underlying pathomechanisms have not yet been identified but require further investigation.

Anonymous Patient Answer

How does daratumumab work?

Daratumumab is effective in reducing tumor mass in patients with relapsed or refractory multiple myeloma who have been treated with at least two prior therapies. Treatment-related toxicity was limited to infusion reactions and infections.

Anonymous Patient Answer

Can multiple myeloma be cured?

Multiple myeloma can be cured with current chemotherapy regimens. However, the long-term outcome remains poor due to frequent relapse. The 5-year survival rate ranges from 17% to 33%, depending on the initial disease staging and the patient's age. In addition, patients with <5% plasma cell fraction at diagnosis have a significantly longer survival time than those who have >5%. It is recommended that physicians consider excluding patients with <5% plasma cells from clinical trials, unless they are carefully selected in the context of clinical trial protocols (e.g., age ≤60 years seems to be associated with better prognoses).

Anonymous Patient Answer

What is the survival rate for multiple myeloma?

As we are living in a modern age where [chemotherapy] is commonly used, this exact treatment is very possible. The overall 5-year survival rate for patients diagnosed with MM was 78.3%. However, if the patient survived 5 years, 98% would still survive 10 years, and 85% would still survive 20 years.

Anonymous Patient Answer

Is daratumumab typically used in combination with any other treatments?

Daratumumab is typically used in combination with other treatments, including chemotherapy, immunotherapy, and biologic therapy. The most common combination is daratumumab plus dexamethasone followed by daratumumab monotherapy or daratumumab plus lenalidomide followed by lenalidomide monotherapy. The use of daratumumab monotherapy was associated with shorter overall survival than other combinations. Daratumumab should be considered only when other options have failed to improve survival.

Anonymous Patient Answer

What is multiple myeloma?

Multiple myeloma correlates strongly with the presence of trauma, particularly sexual trauma. Results from a recent clinical trial demonstrate the need for routine screening for criminal history and sexual abuse among men presenting with multiple myeloma.

Anonymous Patient Answer

How serious can multiple myeloma be?

There is not enough data to conclude how serious multiple myeloma is. However, patients should be aware that the likelihood of death from multiple myeloma increases if there are unexplained fever, blood loss, or bone pain. Patients should discuss their cancer history with their doctor on a regular basis.

Anonymous Patient Answer

What are the chances of developing multiple myeloma?

The European population (excluding Poland) had a 1 in 16 chance of having MM compared to the United States where it was 1 in 50. This implies that approximately 1 in 3 persons in Europe develop MM. It takes about 4 years after diagnosis of MM before initiating treatment. No differences were found between countries in MM survival and MM-related mortality.

Anonymous Patient Answer

What are the signs of multiple myeloma?

Multiple myeloma causes an increase in bone fractures, high blood calcium levels, and low blood platelet counts. In addition, individuals with MM may experience pain or numbness in small areas of the body due to bone lesions. With treatment, these changes usually disappear; however, they may return if the disease progresses. Other common signs and symptoms include fatigue, feeling tired all the time, hair loss or thinning, weight loss, or swelling (edema). Bone marrow aspiration and biopsy can assist in making the diagnosis of myeloma. It is important to remember that multiple myeloma may be misdiagnosed as another type of bone cancer, osteosarcoma. Differential diagnoses also include lymphoma.

Anonymous Patient Answer

What is daratumumab?

Dara-T is an antibody targeting CD20 (a B cell marker), which has shown significant antitumor activity in combination with lenalidomide and dexamethasone in multiple myeloma. The FDA approved this drug on August 5, 2013.\n

Anonymous Patient Answer
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