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Quad Regimen for Multiple Myeloma
Study Summary
This trial will assess if adding ixazomib and daratumumab to lenalidomide as a maintenance treatment following induction with lenalidomide, ixazomib, dexamethasone, and daratumumab will impact progression free survival.
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.Side effects data
From 2013 Phase 4 trial • 122 Patients • NCT01474915Trial Design
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- I have not used any experimental drugs or devices recently.I have COPD or asthma.I cannot take certain medications to prevent blood clots.I do not have any uncontrolled medical or mental health conditions.I do not have any serious heart conditions.I have not had radiation therapy or plasmapheresis recently.I have confirmed multiple myeloma with specific test results.I have had Waldenström's disease or conditions with IgM protein without bone damage.I am using two reliable birth control methods or abstaining from sex.I agree to follow the pregnancy testing schedule as required.I have had treatment or a stem cell transplant for my multiple myeloma, except for emergency steroids.I show signs of my multiple myeloma affecting the lining of my brain recently.I am 18 years old or older.You have tested positive for HIV, hepatitis B, or hepatitis C.I am able to care for myself and perform daily activities.I have a new diagnosis and am not eligible for high-dose chemotherapy with stem cell transplant.I haven't taken strong CYP3A inducers or St. John's wort recently.My condition has caused damage to my organs or shown specific myeloma signs.I haven't had cancer treatment in the last 5 years, except for non-invasive types.I have had severe nerve pain or tingling in the past few months.I have never had plasma cell leukemia or POEMS syndrome.I haven't had major surgery recently or planned soon.You must have a disease that can be measured using specific criteria.Your blood test results need to meet specific criteria before starting treatment.I have been diagnosed with primary AL amyloidosis.
- Group 1: Lenalidomide, Ixazomib, Daratumumab, and Dexamethasone
- Group 2: Lenalidomide
- 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
Are there any other investigations which have utilized Dexamethasone?
"Currently, there are 762 active clinical trials inquiring into the efficacy of Dexamethasone with a total of 171 Phase 3 studies. While the majority is conducted in Joliet, Illinois, this medication has been tested at 26686 locations worldwide."
How many health care facilities are actively conducting this experiment?
"This study is being offered in 12 distinct medical centres across the United States, such as Michigan Cancer Center Research Consortium NCORP situated Spartanburg, Gibbs Cancer Center & Research Institute/Spartanburg Regional Healthcare located in Winston-Salem and Wake Forest Baptist Health found in Chapel Hill."
Who fulfills the eligibility criteria for participation in this research?
"This clinical research is recruiting 188 adults with multiple myeloma aged between 18 and 75. To be eligible, the patient must have reached legal age and a hemoglobin value of ≥20 g/L or <100 g/L below the lowest limit of normal."
How many participants are being enlisted in this research endeavor?
"Affirmative. The clinicaltrials.gov database attests that this medical investigation is still recruiting patients and has been since October 21st 2020. Currently, the study requires 188 participants to be recruited from 12 distinct medical centres."
Is there currently an opportunity for individuals to join the research?
"Confirmed by the clinicaltrials.gov repository, this research is actively seeking volunteers which began recruitment on October 21st 2020 and was last updated September 16th 2022."
Is the age requirement for this trial under twenty years old?
"The minimum age for participants in this trial is 18 and the upper bound is 75. For minors, there are 122 trials available while adults aged 65+ have 1478 clinical tests to choose from."
In what ways is Dexamethasone typically employed to treat various ailments?
"Dexamethasone is commonly prescribed to manage ophthalmic sympathetic conditions. However, it can also be used in certain cases of macular edema and branch retinal vein occlusion that have already been exposed to two systemic chemotherapies."
Has the Federal Drug Administration authorized Dexamethasone for patient use?
"Our team at Power rated the safety of Dexamethasone a 2 on our scale, as Phase 2 trials have provided some evidence for its security but none to back up its efficacy."
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