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Proteasome Inhibitor
BLd Combination Therapy for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Led By Paul Richardson, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up survival rate at 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new combination therapy for multiple myeloma. The goal is to find the highest dose of the combination that can be given safely, and to see how well it works in newly diagnosed patients.
Who is the study for?
This trial is for adults over 18 with newly diagnosed multiple myeloma who haven't had systemic therapy before. They should be relatively active (Karnofsky score ≥60) and not pregnant. Exclusions include serious illnesses, prior cancers (with some exceptions), renal insufficiency, low blood counts, liver enzyme abnormalities, certain heart conditions, uncontrolled diabetes or infections, known drug allergies and HIV.
What is being tested?
The study tests the safety and effectiveness of a combination therapy using Bortezomib, Lenalidomide, and Dexamethasone in patients with new multiple myeloma. It aims to find the highest safe dose of this mix and how well it works together as an initial treatment.
What are the potential side effects?
Possible side effects may include nerve damage (neuropathy), blood clots, bone marrow suppression leading to lower blood cell counts; increased risk of infections; digestive issues like constipation or diarrhea; muscle cramps; fatigue; skin rash; and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pfs rate at 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pfs rate at 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate of the Drug Combination in This Patient Populations.
Secondary study objectives
Estimated 18-month Overall Survival Rate
Estimated 18-month Progression Free Survival (PFS) Rate
Percentage of Patients Who Remained in Response for More Than 18 Months
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: lenalidomide, dexamethasone, bortezomib combinationExperimental Treatment3 Interventions
In this study each cycle will be 21 days and participants will begin the study medication in the clinic on Cycle 1 Day 1. Lenalidomide (capsules) will be taken daily for the first 2 weeks only (Day 1-14). Dexamethasone (tablets) will be taken on Day 1, 2, 4, 5, 8, 9, 11 and 12. Bortezomib will be given intravenously in the outpatient treatment clinic on Day 1, 4, 8 and 11. The third week is a rest period and no study medication will be given.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~2240
Bortezomib
2005
Completed Phase 3
~1410
dexamethasone
1995
Completed Phase 3
~9520
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,169 Total Patients Enrolled
54 Trials studying Multiple Myeloma
44,262 Patients Enrolled for Multiple Myeloma
Brigham and Women's HospitalOTHER
1,666 Previous Clinical Trials
11,840,167 Total Patients Enrolled
13 Trials studying Multiple Myeloma
912 Patients Enrolled for Multiple Myeloma
Beth Israel Deaconess Medical CenterOTHER
854 Previous Clinical Trials
12,930,883 Total Patients Enrolled
13 Trials studying Multiple Myeloma
1,062 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have signs of bleeding from your mouth or inside your body, or your platelets are not working properly.I do not have any serious infections or health conditions.My diabetes is not well-controlled.I have been diagnosed with POEMS syndrome.Your absolute neutrophil count is less than 1000 cells per cubic millimeter.Your liver enzymes (AST or ALT) are more than double the normal level.I am currently taking corticosteroids.My kidney function is reduced with a creatinine level over 2.5 mg/dL.I haven't had a heart attack or severe heart issues in the last 6 months.I have had skin, cervical, breast, or prostate cancer but it was treated successfully.Your hemoglobin level is less than 8.0 grams per deciliter.I have an active hepatitis B or C infection.I have not received any systemic therapy for my multiple myeloma.You are allergic to acyclovir or similar antiviral drugs.You have to have a negative pregnancy test from a blood or urine sample.I have moderate to severe numbness, tingling, or pain in my hands or feet.I am 18 years old or older.You cannot tolerate steroid medications.I have been diagnosed with multiple myeloma.I can care for myself but may not be able to do active work.I have been diagnosed with HIV.
Research Study Groups:
This trial has the following groups:- Group 1: lenalidomide, dexamethasone, bortezomib combination
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.
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