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Proteasome Inhibitor
Doxorubicin + Bortezomib + Dexamethasone for Multiple Myeloma
Phase 2
Waitlist Available
Led By James R. Berenson, MD
Research Sponsored by Oncotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic, newly diagnosed, and previously untreated multiple myeloma
Karnofsky performance status 60-100%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying giving doxorubicin hydrochloride liposome, bortezomib, and dexamethasone to treat patients with newly diagnosed multiple myeloma.
Who is the study for?
This trial is for adults with newly diagnosed multiple myeloma who haven't had treatment before. They should have a certain level of blood cells, no severe illnesses or infections like HIV/hepatitis, and must be able to perform daily activities at least partially on their own. Pregnant women can't join, and participants must agree to use birth control.Check my eligibility
What is being tested?
The study tests how well a combination of doxorubicin hydrochloride liposome (a chemotherapy drug), bortezomib (which blocks enzymes cancer cells need), and dexamethasone (a steroid) works in treating new cases of multiple myeloma compared to standard treatments.See study design
What are the potential side effects?
Possible side effects include nausea, vomiting, hair loss from doxorubicin; nerve damage, fatigue from bortezomib; and increased appetite, mood changes from dexamethasone. Side effects vary by individual.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been recently diagnosed with multiple myeloma and have not received any treatment.
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I can care for myself but may not be able to do active work.
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My kidney function is within the required range for the trial.
Select...
I have been diagnosed with multiple myeloma.
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
Response rate (complete response, very good partial response, partial response, and minimal response) as assessed by modified Bladé criteria at baseline, on day 1 of each course, and at end-of-study
Secondary outcome measures
Changes in 24-hour urine M-protein
Changes in serum M-protein
Duration of response
+5 moreFind a Location
Who is running the clinical trial?
OncotherapeuticsLead Sponsor
22 Previous Clinical Trials
908 Total Patients Enrolled
21 Trials studying Multiple Myeloma
885 Patients Enrolled for Multiple Myeloma
James R. Berenson, MDPrincipal InvestigatorOncotherapeutics
5 Previous Clinical Trials
151 Total Patients Enrolled
5 Trials studying Multiple Myeloma
151 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have enough platelets in your blood, at least 75,000 per cubic millimeter. If your bone marrow is significantly affected, you need at least 50,000 platelets per cubic millimeter.Your hemoglobin level needs to be at least 8.0 grams per deciliter.Your AST and ALT levels in your blood are not more than 3 times the upper limit of normal.Your bilirubin levels in the blood are not more than 2 times the normal limit.I have been recently diagnosed with multiple myeloma and have not received any treatment.You do not have HIV, hepatitis B, or hepatitis C.It has been over 4 weeks since my last immunotherapy, antibody therapy, or radiotherapy.I can care for myself but may not be able to do active work.I do not have plasma cell leukemia.I haven't had severe numbness or pain in my hands or feet recently.My heart is healthy and functions well.I don't have uncontrolled high blood pressure, diabetes, or other serious health or mental issues.Your blood potassium level is higher than the normal range.You have a condition that can be measured.Your blood sodium level is above the lower limit of normal.You need to have a negative pregnancy test.My kidney function is within the required range for the trial.It's been over 4 weeks since my last major surgery and I have recovered.My multiple myeloma can be measured by tests.I do not have POEMS syndrome.You have the specific signs and symptoms needed for the diagnosis.I have not received any treatment for myeloma, except as allowed.I have no allergies to drugs similar to the ones in this trial.I have been diagnosed with multiple myeloma.Your absolute neutrophil count is at least 1,500 per cubic millimeter (or at least 1,000 per cubic millimeter if your bone marrow is heavily affected).I haven't had cancer in the last 5 years, except for skin cancer or cervical pre-cancer.You do not have very high levels of calcium in your blood.You are expected to live for more than 3 months.I haven't taken any experimental drugs in the last 14 days.
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.
Has this medication received regulatory approval from the government?
"There is some data supporting the safety of this treatment, but none indicating efficacy, so it received a score of 2."
Answered by AI
In how many different medical clinics is this study being run today?
"The Loma Linda University Cancer Institute at Loma Linda University Medical Center in Loma Linda, Maryland is the primary location for this study. However, data collection and other operations are also happening out of 12 other satellite locations including San Diego Pacific Oncology and Hematology Associates, Incorporated - Escondido in Escondido, Arizona, and Sutter Cancer Center at Roseville Medical Center in Roseville, New york."
Answered by AI
Are people still being recruited for this experiment?
"This clinical trial, which was posted on July 1st 2008 and last updated December 17th 2013 according to clinicaltrials.gov, is not looking for participants at this time. However, there are 831 other trials that are currently enrolling patients."
Answered by AI
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