Triple Drug Therapy for Multiple Myeloma

(DFCI 10-106 Trial)

Recruiting at45 trial locations

Overseen by Paul Richardson

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Paul Richardson, MD

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

In this research study, we are looking to explore the drug combination, lenalidomide, bortezomib and dexamethasone alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. In this study, HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs progression-free survival by at least 9 months or more, recognizing that particular subgroups may benefit more compared to others.

Research Team

Paul Richardson

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with Multiple Myeloma.

Voluntary written informed consent

I can take care of myself and perform daily activities.

Exclusion Criteria

I have cancer that has spread to my brain.

Receiving any other investigational agents

My platelet count is below 50,000.

Treatment Details

Interventions

• Autologous Stem Cell Transplant (Procedure)
• Bortezomib (Protein Degradation Inhibitor)
• Dexamethasone (Corticosteroid)
• Lenalidomide (Immunomodulatory Agent)

Trial Overview 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.

Participant Groups

Group I: RVD Alone Experimental Treatment 3 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 ASCT Active Control 4 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

Bortezomib is already approved in Canada, Japan for the following indications:

Approved in Canada as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Approved in Japan as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Who Is Running the Clinical Trial?

Paul Richardson, MD

Lead Sponsor

Trials

2

Recruited

780+

Paul G. Richardson, MD

Lead Sponsor

Trials

2

Recruited

780+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Dr. Kevin Tabb

Beth Israel Deaconess Medical Center

Chief Executive Officer since 2021

MD from Hebrew University Hadassah Medical School

Dr. Chi Chang Daniel Siao

Beth Israel Deaconess Medical Center

Chief Medical Officer since 2023

MD from King George’s Medical University

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

Millennium Pharmaceuticals, Inc.

Industry Sponsor

Trials

406

Recruited

46,900+

Dr. Christophe Bianchi

Millennium Pharmaceuticals, Inc.

Chief Medical Officer since 2006

MD from University of Geneva

Dr. Deborah Dunsire

Millennium Pharmaceuticals, Inc.

Chief Executive Officer since 2005

MD from University of Witwatersrand

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

Celgene Corporation

Industry Sponsor

Trials

446

Recruited

58,500+

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University

Cape Cod Hospital

Collaborator

Trials

3

Recruited

25,800+