Your session is about to expire
← Back to Search
Daratumumab After Stem Cell Transplant for Multiple Myeloma
Study Summary
This trial studied how well daratumumab works in treating patients with multiple myeloma after a stem cell transplant. Monoclonal antibodies kill cancer cells that are left after chemotherapy.
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 2022 Phase 3 trial • 665 Patients • NCT00567567Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I am scheduled for a stem cell transplant with a specific chemotherapy dose, adjusted for my kidney function.My organs are strong enough for high dose chemotherapy and a stem cell transplant.I've been cancer-free for 5 years, except for minor skin cancers or early-stage prostate or breast cancer.I have been diagnosed with multiple myeloma, amyloidosis included.You have known allergies or sensitivity to certain types of medications made from human proteins.You have been infected with hepatitis C, unless you have been successfully treated for it.I started my first treatment for multiple myeloma between 2 and 13 months ago.Your total bilirubin level is not more than 1.5 times the upper limit of normal.Your alanine aminotransferase (ALT) level should be no more than 3 times the upper limit of normal.My condition worsened after treatment with daratumumab or a similar drug.I have had an organ or stem cell transplant in the past.I am HIV positive.I have been tested for hepatitis B and know my status.I am a man who will use birth control and not donate sperm during and 6 months after the study.I haven't taken antibiotics for an infection in the last 14 days.I do not have an uncontrolled infection.I am not pregnant or breastfeeding.My multiple myeloma has worsened before joining this study.I have moderate or severe asthma, or my asthma is currently not under control.I have had an autoimmune or inflammatory disorder in the last 3 years, except for stable hypothyroidism, vitiligo, alopecia, or untreated psoriasis.I have not had major surgery in the last 2 weeks.You have a history of a weakened immune system from birth.I have not received any live vaccines in the last 4 weeks.Your AST levels are not more than three times the normal limit.You have enough infection-fighting white blood cells in your body.I can take care of myself and am up and about more than 50% of my waking hours.I am currently on chemotherapy, biologic, or hormonal therapy for cancer.I have serious heart issues, including recent heart attack or unstable angina.I have had plasma cell leukemia or cancer that spread to my brain or spinal cord.You need to have enough CD34+ cells, at least 2.5 million per kilogram of your body weight.I currently have hepatitis A.I have a rare blood disorder such as plasma cell leukemia or Waldenstrom's macroglobulinemia.I have COPD with less than half the normal lung function.My kidneys are functioning well enough (creatinine clearance >= 30 mL/min).I am using a reliable birth control method or my partner is sterilized.I haven't used strong immune-suppressing drugs recently, except for minor exceptions like creams or low-dose steroids.My platelet count is at least 75,000 without recent transfusions.
- Group 1: Treatment (ASCT, melphalan, daratumumab)
- 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
Has the FDA officially sanctioned Autologous Hematopoietic Stem Cell Transplantation?
"A score of 2 was given to Autologous Hematopoietic Stem Cell Transplantation due to the clinical data indicating it has some safety characteristics, but there is yet no evidence that this treatment can be efficacious."
Are applicants younger than forty-five years eligible for this trial?
"This medical trial is open to applicants aged between 18 and 70. Furthermore, there are 54 studies specifically enrolling participants under the age of majority as well as 1056 trials welcoming patients who have surpassed 65 years old."
Could I be approved to join this experiment?
"This medical assessment seeks to involve 40 individuals living with multiple myeloma, aged between 18 and 70. The necessary prerequisites for enrolment are an Eastern Cooperative Oncology Group (ECOG) score of less than or equal to 2."
How many participants are enrolled in this medical experiment?
"Yes, the clinical trial website shows that this research is still accepting participants. It was first made available on July 17th 2019 and recently updated on October 7th 2022. The study requires 40 volunteers from 1 location."
What therapeutic applications is Autologous Hematopoietic Stem Cell Transplantation most often employed for?
"Autologous Hematopoietic Stem Cell Transplantation has been proven to be an effective form of immunomodulation, as well as a viable treatment for stage i mycosis fungoides and haematological disorders such as polycythemia vera (PV) and lymphoma."
Are there any remaining vacancies for prospective participants in this clinical trial?
"According to the data on clinicaltrials.gov, enrolment is still ongoing for this trial which was initially announced on July 17th 2019 and modified most recently in October 7th 2022."
Share this study with friends
Copy Link
Messenger