CLINICAL TRIAL

Talquetamab for Multiple Myeloma

1 Prior Treatment
Refractory
Relapsed
Recruiting · 18+ · All Sexes · Sevilla, Spain

This study is evaluating whether a drug may help treat multiple myeloma.

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About the trial for Multiple Myeloma

Eligible Conditions
Multiple Myeloma · Haematological Malignancies · Hematologic Neoplasms · Neoplasms, Plasma Cell

Treatment Groups

This trial involves 3 different treatments. Talquetamab 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
Talquetamab
DRUG
Experimental Group 2
Talquetamab
DRUG
Experimental Group 3
Talquetamab
DRUG

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 3 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient has been diagnosed with multiple myeloma based on the IMWG diagnostic criteria. show original
The three groups of patients being studied are those with multiple myeloma that can be measured by a central laboratory, those with multiple myeloma that cannot be measured by a central laboratory, and those without multiple myeloma. show original
(pregnancy-specific beta-1-antitrypsin [ps-β-1-AT]) Women who could potentially become pregnant must have a negative pregnancy test before the first dose of the study drug show original
A person's Eastern Cooperative Oncology Group (ECOG) performance status score can range from 0 to 2 show original
This protocol specifies what people are willing and able to do. 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 2 years and 10 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 2 years and 10 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 2 years and 10 months.
View detailed reporting requirements
Trial Expert
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- 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 Talquetamab will improve 1 primary outcome and 18 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Baseline up to 2 years and 10 months.

Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)
BASELINE UP TO 2 YEARS AND 10 MONTHS
The EQ-5D-5L is a generic measure of health status. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). The scores for the 5 separate questions are categorical and cannot be analyzed as cardinal numbers.
BASELINE UP TO 2 YEARS AND 10 MONTHS
Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)
BASELINE UP TO 2 YEARS AND 10 MONTHS
The EORTC- QLQ-Core-30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 6 single symptom items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The recall period is 1 week ("past week") and responses are reported using a verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.
BASELINE UP TO 2 YEARS AND 10 MONTHS
Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)
BASELINE UP TO 2 YEARS AND 10 MONTHS
The PGIS is a single item that assesses severity of the participant's health state, on a 5-point verbal rating scale. Score ranges from 1 (None) to 5 (Very Severe).
BASELINE UP TO 2 YEARS AND 10 MONTHS
Number of Participants with AEs by Severity
UP TO 2 YEARS AND 10 MONTHS
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
UP TO 2 YEARS AND 10 MONTHS
Serum Concentration of Talquetamab
UP TO 2 YEARS AND 10 MONTHS
Serum samples will be analyzed to determine concentrations of talquetamab.
UP TO 2 YEARS AND 10 MONTHS
Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
UP TO 2 YEARS AND 10 MONTHS
An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
UP TO 2 YEARS AND 10 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 are the signs of multiple myeloma?

Anemia (PtIs>7.5 g/L; PtIs<or equal to 7.5 g/L), low platelet counts, high levels of LDH (PtIs>100), an abnormal level of B2microglobulin, and low levels of Beta2 crystallin fragments in serum are features of MM. These signs indicate that most patients with MM have yet to be diagnosed. One of the signs of MM is a low-level Bence Jones protein, which is indicative of MM.

Anonymous Patient Answer

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

About 38% of the US population will develop MM within the next decade, but only 16% of patients with MM will be diagnosed in the US. In order for the diagnosis of MM to be made on a routine basis, the surveillance systems for MM, including clinical epidemiology and treatment of MM, are warranted.

Anonymous Patient Answer

What is multiple myeloma?

Multiple myeloma is a cancer of the plasma cells in bone marrow and causes uncontrolled cell growth. Roughly 1 in 4 patients with the disease become acutely symptomatic, the disease is progressive, and most patients with the disease have symptoms that do not improve.\n

Anonymous Patient Answer

Can multiple myeloma be cured?

The cure rate of myeloma is currently much lower than the success rate reported in prior papers, but the rate of relapse with standard cancer chemotherapy and the probability of cure with newer multimodal treatment regimens are similar.

Anonymous Patient Answer

What causes multiple myeloma?

Multiple myeloma is an incurable disease. However, treatments are available which may improve the chances of a long-term diagnosis and prolong survival. Thus patients and carers need to be given as much information and instructions as possible.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

The common therapeutic approaches in multiple myeloma patients have not changed significantly over time. The majority of patients will reach disease progression and receive a combination of new agents, with the last two lines including bortezomib. In those cases, a single agent will no longer be able to reach remission. In the last few years, one line of drugs – denegron plus prednisone -- has gained a reputation as a high-risk and potent treatment; however, these properties can be used to the advantage of patients in order to reach the best therapeutic response.

Anonymous Patient Answer

What is the latest research for multiple myeloma?

The number one cause of deaths among multiple myeloma patients is kidney disease. Thus, new strategies to prevent kidney damage and to promote healthy kidney function are necessary. New therapies are tested in clinical trials for multiple myeloma patients. However, even if a drug shows positive results in clinical trials for multiple myeloma, it does not guarantee its use in every patient or that it is a safe and effective treatment, since patients who respond to treatment are the ones most likely to benefit from it. Thus, patients have to be thoroughly examined to understand their disease and assess the risks and benefits of each clinical trial. You can learn about the latest multiple myeloma clinical trials by finding the [power(https://www.withpower.

Anonymous Patient Answer

Have there been any new discoveries for treating multiple myeloma?

Results from a recent clinical trial of the studies reported herein will allow us to evaluate the importance in implementing this approach in multiple myeloma patients.

Anonymous Patient Answer

Does multiple myeloma run in families?

The incidence of multiple myeloma in first-degree relatives differs from other cancers and is higher following a non-myelomatous diagnosis. This would suggest that susceptibility to multiple myeloma may run in families.

Anonymous Patient Answer

Has talquetamab proven to be more effective than a placebo?

Overall, the addition of Talq proved to be not more effective in terms of median progression-free survival and median overall survival than the placebo. However, in the first two-year randomized phase III trial it was confirmed that T-DM1 produced a significant prolongation of duration of progression-free survival compared with the reference therapy. On the contrary, in general, it seems that a single intravenous dose of 4 mg of talquinavir (brand name Talq) does not induce a dose limiting toxicity.

Anonymous Patient Answer

How quickly does multiple myeloma spread?

The rate of disease spread was not different among cancer patients with various characteristics: age, BMI, disease stage, or the presence of multiple myeloma protein. Future study using a larger cohort would help answer more important questions about the disease.

Anonymous Patient Answer

How serious can multiple myeloma be?

There is a wide variation in the incidence of multiple myeloma in different countries. This is most likely due to differences in the prevalence of multiple myeloma in different populations. Furthermore, the clinical course of multiple myeloma in a country is determined by the country's healthcare systems. In order to ensure the quality of care for multiple myeloma patients, specific guidelines as well as standardized treatment guidelines need to be developed and adopted across a variety of different countries.

Anonymous Patient Answer
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