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Proteasome Inhibitor
Triple Drug Therapy for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Led By Ajai Chari, MD
Research Sponsored by Herbert Irving Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of multiple myeloma
ECOG performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of doxorubicin hydrochloride liposome, melphalan, and bortezomib for treating patients with relapsed or refractory stage I, stage II, or stage III multiple myeloma.
Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma stages I-III who have tried at least two treatments before. They should be relatively active (able to care for themselves), not pregnant, using contraception if fertile, and free from severe infections, heart conditions, or nerve damage. Participants must also have adequate blood counts and liver function.Check my eligibility
What is being tested?
The study tests a combination of chemotherapy drugs: doxorubicin hydrochloride liposome, melphalan, and bortezomib. It aims to find the safest doses and see how effective they are against multiple myeloma that has come back or didn't respond after previous treatment.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, hair loss, low blood cell counts increasing infection risk or bleeding problems; numbness/tingling in hands/feet; heart issues; liver toxicity; fatigue; appetite loss; mouth sores.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma.
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I can take care of myself and perform daily activities.
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My heart functions well enough for most activities.
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I do not have uncontrolled chest pain.
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My heart test (EKG) shows no signs of immediate heart damage.
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I do not have any ongoing serious infections.
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I have undergone at least 2 treatments for multiple myeloma.
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I have not had a heart attack in the last 6 months.
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My cancer returned after it was completely gone.
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I do not have severe, uncontrolled heart rhythm problems.
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I do not have severe nerve damage.
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My condition is worsening despite treatment.
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My cancer is at an early or intermediate stage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients experiencing treatment-related ≥ grade 3 hematologic or nonhematologic toxicity or treatment-related death (phase I)
Secondary outcome measures
Overall survival (phase II)
Progression-free survival (phase II)
Time to response (phase II)
+1 moreFind a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,121 Total Patients Enrolled
578 Trials studying Multiple Myeloma
188,698 Patients Enrolled for Multiple Myeloma
Herbert Irving Comprehensive Cancer CenterLead Sponsor
33 Previous Clinical Trials
897 Total Patients Enrolled
3 Trials studying Multiple Myeloma
157 Patients Enrolled for Multiple Myeloma
Ajai Chari, MDPrincipal InvestigatorHerbert Irving Comprehensive Cancer Center
6 Previous Clinical Trials
112 Total Patients Enrolled
6 Trials studying Multiple Myeloma
112 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of cancer.I have had a condition where my lymphocytes grow abnormally.I have been diagnosed with multiple myeloma.I am not receiving any other chemotherapy treatments.I can take care of myself and perform daily activities.Your bilirubin level in your blood should be less than 2.0 mg/dL.I am not taking any nonsteroidal anti-inflammatory drugs.I will use effective birth control during and for 4 weeks after the study.I am not currently taking thalidomide.I do not have severe graft-versus-host disease.It's been over 30 days since my last immunosuppressive therapy, except for low-dose prednisone.I am not currently undergoing radiation therapy.I've had a stem cell transplant using my own and then donor cells after chemotherapy.I have been treated with a combination of drugs at the same time.I haven't had severe side effects from cancer treatment, except for hair loss.I haven't had doxorubicin, melphalan, and bortezomib together as treatment.My heart functions well enough for most activities.I do not have uncontrolled chest pain.My heart test (EKG) shows no signs of immediate heart damage.Your heart's pumping function is normal (LVEF ≥ 35% by MUGA).I am not taking more than 10 mg of prednisone or its equivalent daily.I am not receiving any cancer treatment for multiple myeloma.I do not have any ongoing serious infections.I have undergone at least 2 treatments for multiple myeloma.It has been over 3 weeks since my last chemotherapy session.Your platelet count is higher than 50,000 per cubic millimeter.I have not had a heart attack in the last 6 months.I've had a stem cell transplant using my own cells after chemotherapy.My cancer returned after it was completely gone.I do not have severe, uncontrolled heart rhythm problems.You are expected to live for at least 3 more months.I haven't had any cancer except for skin cancer in the last 5 years.I do not have severe nerve damage.You have to have a negative pregnancy test.My condition is worsening despite treatment.Your AST blood test result is not more than 4 times the normal limit.My cancer is at an early or intermediate stage.Your absolute neutrophil count is higher than 1,000 per cubic millimeter.
Research Study Groups:
This trial has the following groups: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.
Is enrollment now open for this research experiment?
"According to the clinicaltrials.gov database, this particular trial has ceased its recruitment efforts as of January 9th 2014 and is no longer seeking patients. Nevertheless, there are 811 other studies that can currently benefit from candidates' participation."
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