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Quadruple Therapy + Stem Cell Transplant for Multiple Myeloma
Study Summary
This trial is testing the effects of giving two drugs before and after stem cell transplant.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My blood test shows more than 20% plasma cells.I have been diagnosed with POEMS syndrome.Your disease can be measured according to specific guidelines from the International Myeloma Working Group.My heart pumps well, with an ejection fraction over 40%.I've had one treatment cycle for my disease within the last 60 days and waited 4 weeks since the last dose.I am on a maintenance treatment with either lenalidomide, pomalidomide, or daratumumab.I have not had major surgery in the last 3 weeks.My condition worsened despite taking daratumumab.I have had only one treatment cycle since my last cancer progression.I do not have severe heart problems like recent heart attacks or very weak heart function.I have used corticosteroids for hypercalcemia, spinal cord issues, or fast-growing myeloma.I am mostly able to care for myself and carry out daily activities.I have had moderate to severe asthma or uncontrolled asthma in the last 2 years.My condition worsened despite treatment with carfilzomib, lenalidomide, and dexamethasone.I am able and willing to sign the consent form.My blood pressure or diabetes is not well-managed.I have over 2 million per kg of my own CD34+ cells stored for transplant.I have severe nerve pain or discomfort.I am planning to undergo a stem cell transplant using my own cells, as per my hospital's guidelines.I have had a stem cell transplant from a donor.I cannot take certain medications, including antivirals or blood thinners.I have used corticosteroids for conditions other than multiple myeloma.Your direct bilirubin level is within the normal range.You have a serious lung condition with high blood pressure in the lungs.Your total bilirubin levels need to be within a certain range and, if they are abnormal, your direct bilirubin levels also need to be within a certain range.My lung function is less than half of what it should be due to COPD.I am allowed to take bisphosphonates.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.My multiple myeloma diagnosis has been confirmed by tests.My myeloma has worsened after 1-3 treatments.Your liver function tests (AST and ALT) are within normal range.You have tested positive for HIV.My myeloma has affected my central nervous system.I have had radiotherapy before.I agree to use birth control methods.I am between 18 and 75 years old.My kidneys are functioning well enough to clear waste.I have an active hepatitis B or C infection.I have experienced severe side effects from carfilzomib or lenalidomide.My stomach or intestines can't absorb medicine taken by mouth.
- Group 1: Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab & HCT
- 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
What maladies is autologous hematopoietic cell transplantation commonly employed to alleviate?
"Autologous hematopoietic cell transplantation is often recommended to treat ophthalmia, sympathetic. Additionally, this therapy has been successful in treating branch retinal vein occlusion, macular edema and other conditions that necessitate at least two prior systemic chemotherapy regimens."
Am I eligible to join the experiment?
"This trial is open to 41 individuals suffering from multiple myeloma who are over 18 and under 75. To be accepted into this program, candidates must meet specific criteria including age requirements and having received no more than one cycle of any therapy within the preceding 60 days. Furthermore, prior treatment with corticosteroids or radiotherapy for indications other than multiple myeloma is acceptable."
Is recruitment for participants still ongoing in this research trial?
"According to the data detailed on clinicaltrials.gov, this study is not presently recruiting participants; however, it was first published in July 2018 and most recently modified in September 2022. There are currently 1,558 trials actively seeking patients at this time."
Does this scientific experiment enlist participants who are over the age of sixty?
"This clinical trial only permits applicants aged 18 to 75 as per the outlined criteria."
What is the cap on enrollments for this research trial?
"At the moment, this trial is not actively seeking participants. It was initially posted on July 2nd 2018 and its last update was recorded on September 20th 2022. If you are looking for alternative trials, there are 807 clinical trials enrolling patients who have multiple myeloma as well as 751 studies involving autologous hematopoietic cell transplants that require volunteers."
What research has already been undertaken concerning autologous hematopoietic cell transplantation?
"Autologous hematopoietic cell transplantation was initially studied in 2002 at the Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. There have been 1400 studies completed since then, with 751 presently recruiting participants; many of these are held in Harrison, New jersey."
How many venues are currently hosting this clinical research?
"This investigation is taking place in 18 locations, such as Harrison, Hackensack and Milwaukee. It might be useful to select the closest trial site available to you so that travelling demands can be minimized."
Has autologous hematopoietic cell transplantation been sanctioned by the FDA?
"Due to its Phase 2 status, limited clinical data on safety and the lack of evidence for efficacy, autologous hematopoietic cell transplantation was estimated as a moderate risk with a score of 2."
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