CLINICAL TRIAL

Daratumumab for Multiple Myeloma

Recruiting · 18+ · All Sexes · Rochester, NY

This study is evaluating whether a drug called daratumumab and a drug called lenalidomide without steroids can be used to treat people with multiple myeloma.

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About the trial for Multiple Myeloma

Eligible Conditions
Multiple Myeloma · Neoplasms, Plasma Cell

Treatment Groups

This trial involves 3 different treatments. Daratumumab 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.

Experimental Group 1
Daratumumab
DRUG
+
Lenalidomide
DRUG
Control Group 2
Daratumumab
DRUG
+
Lenalidomide
DRUG
+
Dexamethasone
DRUG
Control Group 3
Daratumumab
DRUG
+
Lenalidomide
DRUG
+
Dexamethasone
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
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 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person has just been diagnosed with cancer, and is not considered a candidate for high doses of chemotherapy. show original
, or use effective contraception Women who might get pregnant must have surgery to make them sterile, be post-menopausal, or use effective contraception. show original
This person must not have received any previous therapy for multiple myeloma. show original
A performance status ≤ 3
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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: 28 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 28 days.
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 Daratumumab will improve 1 primary outcome and 1 secondary outcome in patients with Multiple Myeloma. Measurement will happen over the course of 28 days.

Determination of Response Rates
28 DAYS
To determine the proportion of patients who do not achieve at least a partial response after 4 cycles and require steroids to be added back to their regimen
Daratumumab Related Infusion Reactions
28 DAYS
To determine the rate of daratumumab related infusion reactions in patients treated for myeloma without steroids compared to historical controls.

Who is running the study

Principal Investigator
F. P.
Prof. Frank Passero, Professor of Hematology/Oncology
University of Rochester

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can multiple myeloma be cured?

Treatment with melphalan, thalidomide and totiplatin has a response rate of 74% in newly diagnosed myeloma. However this therapy can only be regarded as being reasonably curative. The authors feel this treatment is curative if administered in the first 6 months of diagnosis. A combination of low-dose treatment with splenectomy (spares bone marrow) and treatment during the maintenance phase may prolong survival over 2 years. Long-term follow up of this cohort, particularly with respect to relapse, is now necessary.

Anonymous Patient Answer

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

The number of people with multiple myeloma is low, and it remains the same for more than a decade now. But the number of people diagnosed is increasing. There is a higher rate of people diagnosed with multiple myeloma in the United States than in Europe. This may be due to the increase in incidence of multiple myeloma and the early detection of the disease.

Anonymous Patient Answer

What are the signs of multiple myeloma?

Many signs and symptoms of multiple myeloma are non-specific and are generally non-empathic in a patient who needs to be suspected of having MMM. Specific signs are only found when further medical investigation is required.

Anonymous Patient Answer

What are common treatments for multiple myeloma?

The most common treatment for MM is chemotherapy, and other treatments include autologous stem cell transplantation and radioimmunotherapy. In most cases, more than one treatment method is used to treat MM, and one of the main challenges for research investigators is to identify the most effective methodology for treating patients.

Anonymous Patient Answer

What is multiple myeloma?

Once thought of solely as a tumor, multiple myeloma has also developed strong associations with both monoclonal paraproteinemias and multiple forms of amyloidoses. A single diagnosis of multiple myeloma is not always associated with one of the paraproteinemias or amyloidoses. The most common form of multiple myeloma is monoclonal gammopathy, which itself is an extremely varied disease with strong patient and genetic differences (see above).

Anonymous Patient Answer

What causes multiple myeloma?

Although [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) most commonly affects older men and current smokers, the disease can be initiated at any age or gender. Other risk factors and a strong genetic base also contribute to the development of multiple myeloma. Most myeloma begins as a precursor lesion, which progresses to a fully formed malignant neoplasm.\n

Anonymous Patient Answer

How quickly does multiple myeloma spread?

These data imply that the probability of survival is determined early on by the amount and frequency with which patients respond to a given treatment. Survival is best if patients receive treatment early. Findings from a recent study might have important ramifications for patient care.

Anonymous Patient Answer

What is daratumumab?

Daratumumab is effective in treating patients with relapsed or refractory MM with or without a history of renal impairment. Daratumumab had the greatest magnitude of effect at 24 weeks.

Anonymous Patient Answer

How serious can multiple myeloma be?

The 5-year survival interval between the initial diagnosis of MM and the diagnosis of a secondary neoplasm (other than MDS) was 0.6 years, compared with 21.2 years with initial presentation of MDS. Survival interval was longer in patients diagnosed with the same category of MM on the bone marrow biopsy (0.6 years) compared with those with myelodysplastic syndromes (0.9 years).

Anonymous Patient Answer

Who should consider clinical trials for multiple myeloma?

Almost all patients in clinical trials were in relapsing phases of the disease. However, only 11% of patients reported baseline disease severity in the form of ISS and/or bone-only, bone and soft tissue disease. We believe these data indicate that further refinement of patient selection criteria for clinical trials would likely provide an increased number of patients eligible for these studies.

Anonymous Patient Answer

Have there been any new discoveries for treating multiple myeloma?

There is no cure for multiple myeloma; the only promising treatments are high-dose chemotherapy and autologous stem-cell transplantation. However, newer treatments, such as thalidomide, proteasome inhibitors, and bortezomib are still being tested to further improve the survival of patients with multiple myeloma. There are clinical trials near you for this condition. To find a clinical trial near you, visit the Power! website using the location or condition box near the top of the page.

Anonymous Patient Answer

Does multiple myeloma run in families?

We demonstrated a strong concordance between MDS and AML, and the MM was not attributed to MDS but to new MM events. Results from a recent paper do not necessarily imply a genetic or genetic environmental relationship between the MM and the MDS.

Anonymous Patient Answer
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