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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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