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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
Must not have
Known brain metastases
Platelet count <50,000/mm3, within 21 days of registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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 myeloma can be measured through blood or urine tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer that has spread to my brain.
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My platelet count is below 50,000.
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My hemoglobin level is below 8 g/dL.
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I do not have severe heart problems or recent heart attacks.
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I do not have severe infections, uncontrolled diabetes, or mental health issues that could affect my study participation.
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I am allergic or react badly to the study drug or similar drugs.
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My lung function is significantly reduced.
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I have moderate to severe numbness, tingling, or pain in my hands or feet.
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I have primary amyloidosis or myeloma with amyloidosis.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
~2240
Dexamethasone
2007
Completed Phase 4
~2650
Bortezomib
2005
Completed Phase 3
~1410

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterOTHER
859 Previous Clinical Trials
12,931,767 Total Patients Enrolled
13 Trials studying Multiple Myeloma
401 Patients Enrolled for Multiple Myeloma
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
1,704 Previous Clinical Trials
2,606,569 Total Patients Enrolled
27 Trials studying Multiple Myeloma
1,216 Patients Enrolled for Multiple Myeloma
University of MichiganOTHER
1,860 Previous Clinical Trials
6,437,191 Total Patients Enrolled
1 Trials studying Multiple Myeloma
14 Patients Enrolled for Multiple Myeloma
Millennium Pharmaceuticals, Inc.Industry Sponsor
405 Previous Clinical Trials
46,133 Total Patients Enrolled
82 Trials studying Multiple Myeloma
9,269 Patients Enrolled for Multiple Myeloma
Massachusetts General HospitalOTHER
3,023 Previous Clinical Trials
13,317,220 Total Patients Enrolled
36 Trials studying Multiple Myeloma
2,262 Patients Enrolled for Multiple Myeloma
University of California, San FranciscoOTHER
2,591 Previous Clinical Trials
14,900,874 Total Patients Enrolled
19 Trials studying Multiple Myeloma
403 Patients Enrolled for Multiple Myeloma
Celgene CorporationIndustry Sponsor
445 Previous Clinical Trials
57,917 Total Patients Enrolled
74 Trials studying Multiple Myeloma
10,247 Patients Enrolled for Multiple Myeloma
Cape Cod HospitalOTHER
2 Previous Clinical Trials
25,025 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterOTHER
1,976 Previous Clinical Trials
598,771 Total Patients Enrolled
87 Trials studying Multiple Myeloma
85,921 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
~48 spots leftby Dec 2025
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