CLINICAL TRIAL

Daratumumab for Multiple Myeloma

1 Prior Treatment
Refractory
Relapsed
Recruiting · 18+ · All Sexes · Amsterdam, Netherlands

This study is evaluating whether a combination of drugs may help treat multiple myeloma.

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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. Daratumumab 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 1 and are in the first stage of evaluation with people.

Experimental Group 1
Pomalidomide
DRUG
+
Talquetamab
DRUG
+
Teclistamab
DRUG
+
Daratumumab
DRUG
Experimental Group 2
Pomalidomide
DRUG
+
Talquetamab
DRUG
+
Teclistamab
DRUG
+
Daratumumab
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
FDA approved
Daratumumab
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 the other condition 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:
Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
Must have either of the following: a) received at least 3 prior lines of therapy including a proteasome inhibitor (PI) (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an immunomodulatory drug (IMiD) (>=2 cycles or 2 months of treatment) in any order during the treatment or b) disease that is double refractory to a PI and an IMiD
Measurable disease at screening as defined by any of the following: Serum monoclonal protein (M-protein) level >= 1.0 grams per deciliter (g/dL) (in non- immunoglobulin G (IgG) myeloma, an M-protein level >=0.5 g/dL); or Urine M-protein level >=200 milligram (mg)/24 hours; or Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and at Cycle 1, Day 1 predose
You are a woman of childbearing potential who has a negative beta-hCG pregnancy test at screening and a negative urine or serum pregnancy test within 1 day before the first dose of study drug. 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 Cycle 7 Day 1 (each cycle of 28-days)
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to Cycle 7 Day 1 (each cycle of 28-days)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to Cycle 7 Day 1 (each cycle of 28-days).
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 4 primary outcomes and 13 secondary outcomes in patients with Multiple Myeloma. Measurement will happen over the course of Up to 48 Weeks.

Duration of Response (DOR)
UP TO 48 WEEKS
DOR is defined as the time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria.
UP TO 48 WEEKS
Time to Response
UP TO 48 WEEKS
Time to response is defined as the time between date of first dose of study drug and the first efficacy evaluation that the participant has met all criteria for PR or better.
UP TO 48 WEEKS
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
UP TO 48 WEEKS
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.
UP TO 48 WEEKS
Overall Response Rate (ORR)
UP TO 48 WEEKS
ORR is defined as the percentage of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
UP TO 48 WEEKS
Clinical Benefit Rate
UP TO 48 WEEKS
Clinical benefit rate (ORR + minimal response [MR]) is defined as the of participants who have a MR or better according to the IMWG criteria.
UP TO 48 WEEKS
Part 2: Number of Participants With Adverse Events and SAEs by Severity
UP TO 48 WEEKS
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product.
UP TO 48 WEEKS
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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?

Genetic and epigenetic events combined with environmental exposures may combine to initiate the oncogenic process leading to myeloma with or without immunoglobulin secretion. We expect to find significant differences between serum myeloma protein and Igs that highlight their unique and redundant roles in MM pathogenesis.

Anonymous Patient Answer

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

There are an estimated 18,900 new cases of multiple myeloma per year in the United States. This makes multiple myeloma the tenth most common cancer in the country. At the current rate of new diagnoses, it is expected that the number of cases of multiple myeloma will substantially increase in the next decade.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

Treatment includes chemotherapy to induce and maintain remission, autotransplant to control the disease, and/or radiotherapy. Most patients are treated with these treatments before considering bone marrow transplant and/or stem cell transplant as they become available.

Anonymous Patient Answer

What are the signs of multiple myeloma?

Signs of MM include bone and bone marrow lesions, which may be painful and associated with numbness (paresthesia) and decreased range of motion, weakness, loss of appetite, and, in severe cases, anemia and thrombocytopenia (low platelets and white blood cells). Pain may be relieved by NSAIDs, and there may be a fever. The first symptoms of MM may involve the skin, causing skin lesions such as plaques and itching, rash, and erythema (redness) or hyperpigmentation (barking redness).

Anonymous Patient Answer

What is multiple myeloma?

Multiple myeloma is a cancer of bone and marrow, characterized by the rapid proliferation of plasma cells, the abnormal accumulation of such cells, and the deposition of new bone. About 1.4% of the US population is currently diagnosed with multiple myeloma. It typically arises after age 60 and affects approximately 1 man for every 1000 women.\n

Anonymous Patient Answer

Can multiple myeloma be cured?

Multiple myeloma cannot be cured for most patients. The number of patients that are considered to be curable varies widely but patients in complete remission have been recorded as having a very low risk for relapse. However, patients who become symptomatic after a period of remission may have a relatively high risk for dying.

Anonymous Patient Answer

Have there been other clinical trials involving daratumumab?

There have been two main clinical trials: DAR-301 (daro-301) and BOLD-3 (BOR-23054). DAR-301 (daro-301), which is already approved with FDA, failed to meet its primary endpoint (durable response in patients with multiple myeloma following at least five cycles of treatment with bortezomib therapy, with at least 90% of respondents achieving ≥ 60% PFS [progression-free survival, time to disease progression, or death].

Anonymous Patient Answer

What does daratumumab usually treat?

Dar+ patients most often present with advanced disease that is inextremately refractory to other treatments (in particular, bortezomib). In these patients, it can achieve ORR even in the presence of progressive disease, suggesting that darimumab may be more efficacious through alternative mechanisms.

Anonymous Patient Answer

What is the survival rate for multiple myeloma?

The prevalence of MM is increasing around the world. The survival rate of patients with MM is poorer than that of patients with AL, the most common form of bone cancer, which may cause some concern.

Anonymous Patient Answer

How serious can multiple myeloma be?

Multiple myeloma is often an incurable illness, and treatment options for the disease are limited. There is still little understanding of the clinical features and prognosis of the disease, as well as the impact of its treatment. Many of the challenges facing clinicians involve obtaining accurate pre-treatment information on disease trajectory and the extent of disease. It is for this reason that clinicians are not always able to offer a more realistic appraisal of the disease in their patients, in particular when diagnosing the rare patients at an earlier stage.

Anonymous Patient Answer

What is daratumumab?

Results of this trial could not be powered to detect a significant difference in treatment response or overall rate of survival. However, analysis of secondary endpoints suggests that daratumumab is well tolerated, with a low incidence of serious infections and an excellent rate of antibody-mediated adverse events.

Anonymous Patient Answer

Is daratumumab safe for people?

Daratumumab was well tolerated and was associated with no significant improvements in disease response or survival in people with multiple myeloma. Prospective trials are required to validate these findings and enable a recommendation to be made regarding daratumumab for use in people with multiple myeloma.

Anonymous Patient Answer
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