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Monoclonal Antibodies
Immunotherapy + Chemotherapy with Stem Cell Transplant for Multiple Myeloma
Phase 2
Waitlist Available
Led By Samer S Srour
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with high risk multiple myeloma who are transplant candidates, in partial response (PR) or better
Left ventricular ejection fraction greater than 40%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing a combination of immunotherapy and chemotherapy before stem cell transplant to treat multiple myeloma.
Who is the study for?
This trial is for high-risk multiple myeloma or plasma cell leukemia patients who are candidates for stem cell transplant and have at least a partial response to previous treatments. They must be physically able to participate (with specific heart, lung, and kidney function requirements) and agree to follow pregnancy prevention measures if applicable.Check my eligibility
What is being tested?
The study tests the effectiveness of umbilical cord blood-derived natural killer cells combined with elotuzumab, lenalidomide, and high dose melphalan before an autologous stem cell transplant in treating multiple myeloma. It aims to find the best dosage while observing how well these therapies work together.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system changes due to monoclonal antibodies like elotuzumab, as well as typical chemotherapy-related issues such as nausea, fatigue, risk of infection from low blood counts, organ inflammation, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have high-risk multiple myeloma and am eligible for a transplant, with my condition at least partially improved.
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My heart pumps well, with an ejection fraction over 40%.
Select...
I agree to use a condom during sex if my partner can have children, even though I've had a vasectomy.
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I have a cord blood unit that matches my HLA markers.
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I can take care of myself and perform daily activities without help.
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My kidneys are functioning well, with a creatinine clearance rate of at least 60 ml/min.
Select...
I have plasma cell leukemia and am eligible for a transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose of umbilical cord blood (UCB)-derived natural killer (NK) cells
Minimal residual disease (MRD) rate
Overall survival (OS)
+2 moreSecondary outcome measures
Duration of infused umbilical cord blood (UCB)-natural killer (NK) cells in new host
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, UCB-derived NK cells, transplant)Experimental Treatment7 Interventions
Patients receive elotuzumab IV over 2-5 hours on day -15 and -8, lenalidomide PO QD on days -8 to -2, high-dose melphalan IV over 30 minutes on day -7, and UCB-derived NK cells IV over 1 hour on day -5. Patients undergo autologous stem cell transplant on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Melphalan
2008
Completed Phase 3
~1500
Natural Killer Cell Therapy
2008
Completed Phase 2
~110
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1730
Elotuzumab
2016
Completed Phase 3
~800
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,144 Total Patients Enrolled
452 Trials studying Leukemia
31,467 Patients Enrolled for Leukemia
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,417 Total Patients Enrolled
1,514 Trials studying Leukemia
384,748 Patients Enrolled for Leukemia
Samer S SrourPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to thalidomide or lenalidomide, or have had a severe skin rash from taking them before.I have high-risk multiple myeloma and am eligible for a transplant, with my condition at least partially improved.My heart pumps well, with an ejection fraction over 40%.I agree to use a condom during sex if my partner can have children, even though I've had a vasectomy.I have a cord blood unit that matches my HLA markers.I can take care of myself and perform daily activities without help.I do not have any uncontrolled illnesses that could affect my participation.My kidneys are functioning well, with a creatinine clearance rate of at least 60 ml/min.I agree to follow the pregnancy testing schedule as required.Your lung test shows that your ability to transfer oxygen is at least 40% of what is expected for someone your age and size.I have plasma cell leukemia and am eligible for a transplant.Your bilirubin levels are within a certain range.You have had allergic reactions to drugs similar to melphalan.I do not have HIV.Your SGPT level in the blood is less than 3 times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (chemotherapy, UCB-derived NK cells, transplant)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At what age are patients eligible for this research study?
"This particular study only allows patients aged 18-75 to enroll. There are 64 other clinical trials available for people under the age of 18 and 1154 for those over 65."
Answered by AI
Are there any open vacancies for this clinical research program?
"This study is no longer looking for new participants. The trial began on June 10th, 2013 and ended on August 18th, 2022. There are currently 840 other clinical trials related to neoplasms, plasma cell seeking patients and 343 trials involving Elotuzumab that are open for enrollment."
Answered by AI
How is Elotuzumab used to help patients?
"Elotuzumab is a potential treatment for stage i mycosis fungoides, polycythemia vera (pv), and patients that have undergone two or more rounds of systemic chemotherapy."
Answered by AI
How many people can join this trial at most?
"Unfortunately, this particular study is no longer looking for participants. The trial was initially posted on 6/10/2013 and ended recruitment on 8/18/2022. However, there are presently 840 clinical trials actively searching for participants with neoplasms and plasma cell. Additionally, 343 trials for Elotuzumab are also recruiting patients."
Answered by AI
Has Elotuzumab been given the green light by the FDA?
"Since this is a Phase 2 trial, meaning that while there is some evidence to support safety, there is none for efficacy, we have given Elotuzumab a score of 2."
Answered by AI
How do I go about signing up for this clinical trial?
"This study is only considering patients that have neoplasms, plasma cell and are between 18-75 years old. They will be looking to accept a total of 72 people into the trial."
Answered by AI
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