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Lenalidomide +/- Daratumumab for Multiple Myeloma (DRAMMATIC Trial)
DRAMMATIC Trial Summary
This trial is testing two different treatments for myeloma: Lenalidomide for 2 years, or Lenalidomide plus Daratumumab/rHuPH20. Patients will be followed for up to 15 years to see which treatment is more effective.
DRAMMATIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDRAMMATIC Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DRAMMATIC Trial Design
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Who is running the clinical trial?
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- My liver is working well.I started my initial cancer treatment within the last year and have completed at least two cycles.I haven't had severe asthma in the last 2 years and my asthma is currently under control.I started my initial cancer treatment within the last year and have completed at least two cycles.I can take and swallow pills whole.My kidney function is normal.I can go back to the transplant center for my treatment.I am eligible for a transplant or had one within the last 6 months.My multiple myeloma has not spread to my brain or spinal cord.I had a physical exam within the last 28 days.My cancer has not worsened before signing up for this trial.You are eligible if your disease can be measured using a blood test that shows at least 100 mg/L of the involved light chain.I am willing and able to take medication to prevent blood clots.I do not have any ongoing serious infections.All the medical tests to determine the current state of the disease must be completed within 60 days before starting the study. The results of these tests will be recorded on specific forms.My multiple myeloma does not only produce non-detectable levels of proteins in blood and urine.I have multiple myeloma and received treatment before a stem cell transplant.I was diagnosed with multiple myeloma and received treatment before a stem cell transplant.I have not had any organ transplants or bone marrow transplants.I can tolerate lenalidomide and daratumumab treatments.I am between 18 and 75 years old.I had a physical exam within the last 28 days.I am registered for the first part of the trial and have finished my initial treatment.I will provide samples for minimal residual disease testing and future research.I have HIV, am on treatment, and my viral load is undetectable.I have not failed to respond to treatments with lenalidomide or daratumumab.I do not have any severe illnesses that are not under control.My lung function is more than half of what is expected for someone my age and size.I do not have smoldering myeloma.I have not had any other types of cancer before.I am between 18 and 75 years old.I can take care of myself but might not be able to do heavy physical work.My organs are not affected by amyloidosis.You should not have hepatitis C.
- Group 1: Arm 1: Lenalidomide
- Group 2: Arm 2: Lenalidomide + Daratumumab/rHuPH20
- Group 3: Arm 1a: Continue Lenalidomide
- Group 4: Arm 2b: Stop Lenalidomide + Daratumumab/rHuPH20
- Group 5: Study Entry / Screening
- Group 6: Arm 1b: Stop Lenalidomide
- Group 7: Arm 2a: Continue Lenalidomide + Daratumumab/rHuPH20
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
For which type of patient is this clinical trial looking for volunteers?
"The study's aim is to enroll 1100 patients that have a diagnosis of multiple myeloma and are between 18 to 75 years old."
Are they looking for more test subjects at this time?
"That is accurate. The online information hub for clinical trials, clinicaltrials.gov, has the latest update that this trial is looking for 1100 patients from 100 sites. The trial was first posted on 6/27/2019."
Are there precedent treatments that use Daratumumab/rHuPH20?
"The first study involving daratumumab/rHuPH20 took place in 2004 at University of Wisconsin Carbone Cancer Center. As of right now, there have been a total of 418 completed trials. Presently, there are 395 clinical trials actively recruiting participants, a majority of which are based in Durham, North carolina."
How many subjects are participating in this clinical trial?
"Janssen, LP is sponsoring this clinical trial which requires 1100 participants that meet the inclusion criteria. This study will be conducted at various sites, two of which are Duke University Medical Center in Durham, North carolina and Oklahoma Cancer Specialists and Research Institute-Tulsa in Tulsa, Oklahoma."
Is this clinical trial restricted to senior citizens?
"This trial is enrolling individuals that fall between 18 to 75 years old."
Can Daratumumab/rHuPH20 be legally obtained in the United States?
"The safety of Daratumumab/rHuPH20 has been well established in Phase 3 trials, so our team has given it a score of 3."
What are the top indications for Daratumumab/rHuPH20?
"Daratumumab/rHuPH20 can be used to treat patients who have already tried other systemic chemotherapy regimens. Additionally, this medication can be used to treat inflammatory breast cancer (ibc), amyloidosis, and refractory multiple myeloma."
Who else is applying?
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