← Back to Search

Protein Degradation Inhibitor

Triple Drug Therapy for Multiple Myeloma (DFCI 10-106 Trial)

Phase 3
Waitlist Available
Research Sponsored by Paul Richardson, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Multiple Myeloma, according to the International Myeloma Foundation 2003 Diagnostic Criteria
ECOG performance status </= 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

DFCI 10-106 Trial Summary

This trial is testing a new combination of drugs to treat cancer. The drugs are lenalidomide, bortezomib, and dexamethasone. They are testing it in patients with multiple myeloma who have not been treated before.

Who is the study for?
This trial is for individuals up to age 65 with newly diagnosed Multiple Myeloma, who are generally in good health (ECOG </=2) and have not received systemic therapy for MM. They must have a negative HIV test, no severe neuropathy or respiratory issues, not be pregnant or breastfeeding, and their blood counts and organ functions need to meet specific criteria.Check my eligibility
What is being tested?
The study tests the effectiveness of lenalidomide, bortezomib, dexamethasone alone versus combined with autologous stem cell transplantation in treating Multiple Myeloma. The goal is to see if high-dose treatment extends progression-free survival by at least 9 months compared to conventional doses.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system suppression such as increased risk of infections, blood count changes leading to anemia or bleeding risks, nerve damage that can cause pain or numbness (neuropathy), digestive problems like nausea or constipation, and possible heart complications.

DFCI 10-106 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Multiple Myeloma.
Select...
I can take care of myself and perform daily activities.
Select...
My myeloma can be measured through blood or urine tests.

DFCI 10-106 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median Progression-Free Survival (PFS)
Secondary outcome measures
5-Year Overall Survival (OS)
5-Year Time to Progression (TTP)
5-year Cumulative Incidence of Second Primary Malignancy (SPM)
+11 more

DFCI 10-106 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RVD AloneExperimental Treatment3 Interventions
All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (D) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD Alone participants received five additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, off-study salvage transplantation was recommended but not mandated for RVD Alone participants at relapse. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
Group II: RVD plus ASCTActive Control4 Interventions
All participants received one cycle of Lenalidomide (R), bortezomib (V) and dexamethasone (d) and then were randomized. All participants then received two additional RVD cycles, followed by stem-cell collection. RVD plus autologous stem cell transplant (ASCT) participants received high-dose melphalan (200 mg/m2, adjusted for ideal body weight) ASCT and, upon recovery (~day 60), two additional RVD cycles. Maintenance in both arms comprised daily lenalidomide 10 mg, escalated to 15 mg if tolerated, until disease progression, unacceptable toxicity, or withdrawal from treatment or study. After finishing protocol-specified treatment, RVD plus ASCT participants could undergo a second transplant. RVD cycle duration=21 days R: 25 mg oral on days 1-14 V: 1.3 mg per square meter of body surface area IV or subcutaneous on days 1, 4, 8, and 11 D: 20 mg oral (cycles 1-3) or 10 mg (cycles 4-8) on days 1, 2, 4, 5, 8, 9, 11, and 12
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1480
Dexamethasone
2007
Completed Phase 4
~2590
Bortezomib
2005
Completed Phase 2
~1140

Find a Location

Who is running the clinical trial?

Paul Richardson, MDLead Sponsor
1 Previous Clinical Trials
61 Total Patients Enrolled
1 Trials studying Multiple Myeloma
61 Patients Enrolled for Multiple Myeloma
Emory UniversityOTHER
1,636 Previous Clinical Trials
2,559,844 Total Patients Enrolled
25 Trials studying Multiple Myeloma
1,249 Patients Enrolled for Multiple Myeloma
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
57,507 Total Patients Enrolled
73 Trials studying Multiple Myeloma
9,820 Patients Enrolled for Multiple Myeloma

Media Library

Bortezomib (Protein Degradation Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01208662 — Phase 3
Multiple Myeloma Research Study Groups: RVD Alone, RVD plus ASCT
Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT01208662 — Phase 3
Bortezomib (Protein Degradation Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01208662 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any subjects needed to complete this research?

"The listed clinical trial is not presently recruiting patients, based on information found on clinicaltrials.gov. This study was initially posted on October 1st, 2010, with the most recent edit being on April 13th, 2022. However, there are 1589 other trials that are actively enrolling patients."

Answered by AI

What are the guidelines for who can and cannot participate in this experiment?

"Eligible patients for this study are those suffering from multiple myeloma and between the ages of 18-65. Currently, the study is looking to enroll 660 patients."

Answered by AI

Has the FDA greenlit Lenalidomide for public consumption?

"Lenalidomide has received a score of 3 for safety. This is because Phase 3 trials- of which this is one- provide some evidence of efficacy in addition to data supporting safety from multiple rounds of testing."

Answered by AI

Could you please list the different hospitals where this trial is taking place?

"Some of the 46 locations where this trial is enrolling patients include Dana-Farber Cancer Institute in Boston, Columbia University in New york, and New hampshire Oncology and Hematology in Concord."

Answered by AI

What are some of the common diseases that Lenalidomide has been shown to help?

"Lenalidomide is often used to treat ophthalmia, sympathetic. However, it is also a viable option for managing a variety of other conditions, such as at least two prior systemic chemotherapy regimens, branch retinal vein occlusion, and macular edema."

Answered by AI

Are individuals over the age of 30 able to participate in this experiment?

"In order for an individual to qualify to take part in this research, they must be between 18-65 years old."

Answered by AI

How many individuals are currently signed up to participate in this clinical trial?

"At the moment, this clinical trial is not recruiting patients. The opening date was October 1st 2010 and the most recent update was on April 13th, 2022. There are currently 826 clinical trials related to multiple myeloma and 763 trials concerning lenalidomide that are actively enrolling patients."

Answered by AI

Could you provide some context for Lenalidomide's clinical trial history?

"The first documented study of lenalidomide was in 2002 at Manitoba Blood & Marrow Transplant Program CancerCare Manitoba. As of now, there are 763 active clinical trials and 1608 completed ones. The majority of these studies taking place in Boston, Massachusetts."

Answered by AI
Recent research and studies
The Cancer JournalJournal
From VAD to VRD
Parmar, Harsh, David H. Vesole, and Noa Biran. 2021. “From VAD to VRD”. The Cancer Journal. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ppo.0000000000000522.
The Cancer JournalJournal
From VAD to VRD
Parmar, Harsh, David H. Vesole, and Noa Biran. 2021. “From VAD to VRD”. The Cancer Journal. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ppo.0000000000000522.
New England Journal of MedicineJournal
Triplet Therapy, Transplantation, and Maintenance Until Progression in Myeloma
Richardson, Paul G., Susanna J. Jacobus, Edie A. Weller, Hani Hassoun, Sagar Lonial, Noopur S. Raje, Eva Medvedova, et al.. 2022. “Triplet Therapy, Transplantation, and Maintenance Until Progression in Myeloma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2204925.
New England Journal of MedicineJournal
Triplet Therapy, Transplantation, and Maintenance Until Progression in Myeloma
Richardson, Paul G., Susanna J. Jacobus, Edie A. Weller, Hani Hassoun, Sagar Lonial, Noopur S. Raje, Eva Medvedova, et al.. 2022. “Triplet Therapy, Transplantation, and Maintenance Until Progression in Myeloma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2204925.
All > Multiple Myeloma > Revlimid
~50 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top