CLINICAL TRIAL

Cilta-cel for Multiple Myeloma

Locally Advanced
Newly Diagnosed
Recruiting · 18+ · All Sexes · Salamanca, Spain

This study is evaluating whether a new treatment for multiple myeloma is better than the standard treatment.

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About the trial for Multiple Myeloma

Eligible Conditions
Multiple Myeloma · Neoplasms, Plasma Cell

Treatment Groups

This trial involves 2 different treatments. Cilta-cel is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Experimental Group 1
Bortezomib
DRUG
+
Dexamethasone
DRUG
+
Lenalidomide
DRUG
Experimental Group 2
Cyclophosphamide
DRUG
+
Fludarabine
DRUG
+
Bortezomib
DRUG
+
Dexamethasone
DRUG
+
Cilta-cel
DRUG
+
Lenalidomide
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved
Bortezomib
FDA approved
Dexamethasone
FDA approved
Lenalidomide
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 the other condition listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Documented diagnosis of multiple myeloma (MM) according to International Myeloma Working Group (IMWG) diagnostic criteria
Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age; or Ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or Deferral of high-dose chemotherapy with ASCT as initial treatment
A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy tests (beta-human chorionic gonadotropin) prior to starting Bortezomib, Lenalidomide and Dexamethasone (VRd) and must agree to further testing during the study.
Clinical laboratory values meeting the following criteria during the screening phase: hemoglobin greater than or equal to (>=) 8.0 g/dL (>=5 millimoles per liter [mmol/L]), recombinant human erythropoietin use is permitted; platelets >=75 *10^9/L; absolute lymphocyte count >=0.3 *10^9/L; absolute neutrophil count (ANC) >=1.0 ×10^9/L (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to (<=) 3.0 * upper limit of normal (ULN); estimated glomerular filtration rate >=40 milliliter per minute/1.73 meter square (mL/min/1.73 m^2) based upon modified diet in renal disease formula (MDRD-4) calculation or a 24-hour urine collection; total bilirubin <=2.0 * ULN; except in participants with congenital hyperbilirubinemia, such as Gilbert syndrome (in which case direct bilirubin <=2.0 * ULN is required)
You have a performance status of 0 or 1. show original
You have measurable disease as defined by any of the following: Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=)1. show original
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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 1 year
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 1 year.
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 Cilta-cel will improve 1 primary outcome and 21 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Up to Day 112.

Arm B: Systemic Cytokine Concentrations
UP TO DAY 112
Serum or plasma proteomic profiling of cytokines (such as interleukin [IL] 6, IL-15, and IL 10) concentrations will be measured for biomarker assessment.
UP TO DAY 112
Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Items
UP TO 161 DAYS
The National Cancer Institute's PRO-CTCAE is an item library of common adverse events experienced by people with cancer that are appropriate for self-reporting. Each symptom selected for inclusion can be rated by up to 3 attributes characterizing the presence/frequency, severity, and/or interference that ranges from 0 to 4 with higher scores indicating higher frequency or greater severity/impact.
UP TO 161 DAYS
MRD Negative CR at 9 Months
9 MONTHS
MRD negative CR rate at 9 months is defined as the percentage of participants who achieve MRD negative CR status at 9±3 months after the randomization date.
9 MONTHS
Progression Free Survival (PFS)
UP TO 4 YEARS AND 5 MONTHS
Progression-free survival is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first.
UP TO 4 YEARS AND 5 MONTHS
Change from Baseline in Health-Related Quality of Life as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score
BASELINE UP TO 12 YEARS AND 5 MONTHS
The PGIS uses 2 items to assess the participant's perception of the severity of their disease symptoms and impact using a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
BASELINE UP TO 12 YEARS AND 5 MONTHS
Change from Baseline in Health-Related Quality of Life as Assessed by MySIm-Q Scale Score
BASELINE UP TO 12 YEARS AND 5 MONTHS
The MySIm-Q is a disease-specific PRO assessment complementary to the EORTC-QLQ-C30. It includes 17 items with recall period of "7 days" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity/impact.
BASELINE UP TO 12 YEARS AND 5 MONTHS
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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 is multiple myeloma?

Multiple myeloma is a rare disease with an estimated incidence rate of 1.5 cases per 100,000 person-years in the USA. Its average survival time is 5 years. While several treatments exist for multiple myeloma, only two drugs (bortezomib and lenalidomide) are FDA approved for the disease, meaning they are widely used. However, there is no consensus on how to treat multiple myeloma patients. Because of this, there are many ongoing clinical trials being conducted at universities and hospitals across the country. Overall, the most effective treatments are still under study and research. To find active clinical trials in your area, you can go to [Power(http://wwwncdi.

Anonymous Patient Answer

What causes multiple myeloma?

Multiple myeloma is caused by the abnormal production of immunoglobulin G (IgG), and IgG is produced by B lymphocytes. The discovery of the B cell helps us understand how we develop our own immune system. In addition to autoimmune diseases, there are many other autoimmune diseases which have similar features to multiple myeloma including celiac disease, lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, Hashimoto's thyroiditis, Behçet's disease, type 1 diabetes, multiple sclerosis, and sarcoidosis.

Anonymous Patient Answer

Does multiple myeloma run in families?

Results from a recent clinical trial shows that myeloma runs in families, but the penetrance of myeloma appears to be very low. The finding that there were more affected siblings than expected by chance suggests an autosomal dominant inheritance pattern. The genetic basis of familial myeloma will likely remain unknown until further family members with myeloma are studied.

Anonymous Patient Answer

What is the primary cause of multiple myeloma?

The majority of [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) cases have an unknown cause. The risk factors for multiple myeloma include exposure to environmental pollutants and radiation. The International Myeloma Working Group found that ionizing radiation was associated with increased risk of multiple myeloma and showed that this association depended on the type of radiation. A causal relationship between ionizing radiation and multiple myeloma has not been established. Other studies suggest that there might be an association between dietary vitamins D and E and the development of multiple myeloma; however, no clear evidence supports this claim. The incidence rate of multiple myeloma increases with age; thus, the probability of developing multiple myeloma increases with age.

Anonymous Patient Answer

What is the average age someone gets multiple myeloma?

The median age for MM was 67, which was similar to the age of 58 for all cancer cases during 2008-2011. However, the estimates were based on cases detected through surveillance rather than through an active case-finding process.

Anonymous Patient Answer

What are the latest developments in cilta-cel for therapeutic use?

Cilta-cel inhibits two forms of CD19 on B cells, IgM and IgG. It also targets the T cell receptor (TCR), inhibiting their activation and proliferation. In addition, it preferentially targets abnormal pre-B lymphocytes. Clinical studies have reported that patients receiving Cilta-cel had significant improvement in symptoms, such as fatigue, nausea, night sweats, loss of appetite, and general discomfort. The drug was approved by the U.S. Food and Drug Administration (FDA) in 2013.

Anonymous Patient Answer

Have there been any new discoveries for treating multiple myeloma?

There have only been a few newly discovered agents that showed promising results in MM. The current standard of care is to use high doses of alkylating agents plus steroids. In the past few years, there has been interest in developing other novel techniques such as bortezomib and lenalidomide. These agents targeting proteasome inhibitors or immunosuppressive agents, respectively, are being investigated. A recently completed trial suggests that there may be benefit to giving autologous stem cell transplantation before the start of the first line therapy. However, these treatments are still experimental and more data are needed to determine their role in treating MM.

Anonymous Patient Answer

Does cilta-cel improve quality of life for those with multiple myeloma?

[Cilta-cel] increased anxiety and depression scores, decreased HRQoL, and reduced overall survival in MM patients (P=0.003). Interestingly, improved HRQoL was maintained at 24 months post-treatment. Findings from a recent study will need to be confirmed in randomized controlled trials.

Anonymous Patient Answer

Can multiple myeloma be cured?

A small proportion of patients with multiple myeloma will experience a complete remission regardless of therapy. Recent findings demonstrate that patients are likely to succumb to the disease before achieving such an outcome.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

MM is an incurable disease, and patients usually survive 5 years after diagnosis. Treatment for MM is typically based on its staging (see definition below) and the risk category a patient falls into. Cyclophosphamide is used as initial therapy; with or without steroids, depending on the risk category. The goal of chemotherapy is to induce remission in as many patients as possible. In those treated with steroid alone, they should receive high dose intravenous cyclophosphamide weekly for 2 to 3 months. Follow up evaluations are then needed every 6 months, and later every 12 months.

Anonymous Patient Answer

Have there been other clinical trials involving cilta-cel?

Cilta-cel has yet to show any benefit in multiple myeloma. There have been different combinations used for phase III trials. There is no evidence to support the superiority of one formulation over another. Ixazomib failed to get FDA approval and was voluntarily withdrawn from further development. Nevertheless, cilta-cel remains an option for patients with multiple myeloma.

Anonymous Patient Answer
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