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Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65 (DFCI 10-106)

Primary Purpose

Multiple Myeloma

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lenalidomide
Bortezomib
Dexamethasone
Autologous Stem Cell Transplant
Sponsored by
Paul Richardson, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Lenalidomide, Bortezomib, Dexamethasone, Stem Cell Transplant, Myeloma, Multiple Myeloma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Multiple Myeloma, according to the International Myeloma Foundation 2003 Diagnostic Criteria
  • Documented symptomatic myeloma, with organ damage related to myeloma with laboratory assessments performed within 21 days of registration
  • Myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains.
  • ECOG performance status </= 2
  • Negative HIV blood test
  • Voluntary written informed consent

Exclusion Criteria:

  • Pregnant or lactating female
  • Prior systemic therapy for MM (localized radiotherapy allowed if at least 7 days before study entry, corticosteroids allowed if dose </= equivalent of 160 mg dexamethasone over 2 weeks)
  • Primary amyloidosis (AL) or myeloma complicated by amylosis
  • Receiving any other investigational agents
  • Known brain metastases
  • Poor tolerability or allergy to any of the study drugs or compounds of similar composition
  • Platelet count <50,000/mm3, within 21 days of registration
  • ANC <1,000 cells/mm3, within 21 days of registration
  • Hemoglobin <8 g/dL, within 21 days of registration
  • Hepatic impairment (>/= 1.5 x institutional ULN or AST (SGOT), ALT (SGPT), or alkaline phosphatase >2 x ULN). Patients with benign hyperbilirubinemia are eligible.
  • Renal insufficiency (serum creatinine >2.0 mg/dl or creatinine clearance <50 ml/min, within 21 days of registration)
  • Respiratory compromise (DLCO < 50%)
  • Clinical signs of heart or coronary failure or LVEF < 40%. Myocardial infarction within 6 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conductive system abnormalities
  • Intercurrent illness including, but not limited to ongoing or active severe infection, known infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements
  • Previous history of another malignant condition except for basal cell carcinoma and stage I cervical cancer. If malignancy was experienced more than 2 years ago and confirmed as cured, these participants may be considered for the study on case by case basis with PI discussion.
  • Inability to comply with an anti-thrombotic treatment regimen
  • Peripheral neuropathy >/= Grade 2

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Comprehensive Cancer Center
  • City of Hope
  • University of California at San Diego
  • University of California, San Francisco
  • Stanford University
  • Colorado Blood Cancer Institute
  • University of Florida
  • H. Lee Moffitt Cancer Center
  • Emory University
  • Mountain States Tumor Institute at St. Luke's Regional Medical Center
  • University of Chicago
  • Ochsner Foundation Clinic
  • Eastern Maine Medical Center
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center
  • Cape Cod Healthcare
  • Newton-Wellesley Hospital
  • University of Michigan
  • Barbara Ann Karmanos Cancer Institute
  • University of Mississippi Medical Center
  • New Hampshire Oncology and Hematology
  • New Hampshire Oncology and Hematology
  • New Hampshire Oncology and Hematology
  • State University of New York Downstate Medical Center
  • Roswell Park Cancer Institute
  • North Shore Long Island Jewish Health System
  • Memorial Sloan Kettering Cancer Center
  • Mount Sinai Medical Center
  • Columbia University
  • University of Rochester Medical Center
  • UNC Lineberger Comprehensive Cancer Center
  • Duke University
  • Wake Forest University
  • Ohio State University Medical Center
  • Oregon Health and Sciences
  • University of Pennsylvania Medical Center
  • Fox Chase Cancer Center
  • University of Pittsburgh Medical Center
  • Vanderbilt University
  • University of Texas Southwestern Medical Center
  • Baylor College of Medicine
  • MD Anderson Cancer Center
  • Huntsman Cancer Institute
  • Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

High Dose Treatment

High Dose Treatment with SCT

Arm Description

Lenalidomide, bortezomib, dexamethasone. Stem cell collection. Maintenance Lenalidomide.

Lenalidomide, bortezomib, dexamethasone. Stem cell collection. Autologous Stem Cell Transplant. Maintenance Lenalidomide.

Outcomes

Primary Outcome Measures

Primary Outcome
To compare progression-free survival (PFS) between Arm A and Arm B.

Secondary Outcome Measures

Secondary Outcome
To compare the response rates (RR) between the two arms.
Secondary Outcome
To compare time to progression (TTP) between the two arms.
Secondary Outcome
To compare the overall survival (OS) between the two arms.
Secondary Outcome
To compare toxicity between the two arms.
Secondary Outcome
To define genetic prognostic groups evaluated by gene expression profiling (GEP).
Secondary Outcomes
To examine the best treatment in each GEP-defined prognostic group.
Secondary Outcome
To compare quality of life (QOL) between the two arms.
Secondary Outcome
To collect medical resource utilization (MRU) information which may be used in economic evaluation models.

Full Information

First Posted
September 23, 2010
Last Updated
April 18, 2023
Sponsor
Paul Richardson, MD
Collaborators
Celgene Corporation, Millennium Pharmaceuticals, Inc., Massachusetts General Hospital, Cape Cod Hospital, Beth Israel Deaconess Medical Center, Emory University, University of Michigan, Fox Chase Cancer Center, Memorial Sloan Kettering Cancer Center, Fred Hutchinson Cancer Center, Barbara Ann Karmanos Cancer Institute, Duke University, University of California, San Francisco, University of Chicago, M.D. Anderson Cancer Center, UNC Lineberger Comprehensive Cancer Center, Roswell Park Cancer Institute, Stanford University, University of Mississippi Medical Center, Icahn School of Medicine at Mount Sinai, Wake Forest University Health Sciences, University of Arizona, OHSU Knight Cancer Institute, Eastern Maine Medical Center, University of California, San Diego, University of Alabama at Birmingham, University of Pittsburgh Medical Center, Ochsner Health System, University of Texas Southwestern Medical Center, State University of New York - Downstate Medical Center, Newton-Wellesley Hospital, Baylor College of Medicine, City of Hope Medical Center, University of Florida, Northwell Health, H. Lee Moffitt Cancer Center and Research Institute, Vanderbilt University Medical Center, Ohio State University, Huntsman Cancer Institute, Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT01208662
Brief Title
Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65
Acronym
DFCI 10-106
Official Title
A Randomized, Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib, and Dexamethasone (RVD) to High-Dose Treatment With Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients Up to 65 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2010 (Actual)
Primary Completion Date
June 2022 (Actual)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul Richardson, MD
Collaborators
Celgene Corporation, Millennium Pharmaceuticals, Inc., Massachusetts General Hospital, Cape Cod Hospital, Beth Israel Deaconess Medical Center, Emory University, University of Michigan, Fox Chase Cancer Center, Memorial Sloan Kettering Cancer Center, Fred Hutchinson Cancer Center, Barbara Ann Karmanos Cancer Institute, Duke University, University of California, San Francisco, University of Chicago, M.D. Anderson Cancer Center, UNC Lineberger Comprehensive Cancer Center, Roswell Park Cancer Institute, Stanford University, University of Mississippi Medical Center, Icahn School of Medicine at Mount Sinai, Wake Forest University Health Sciences, University of Arizona, OHSU Knight Cancer Institute, Eastern Maine Medical Center, University of California, San Diego, University of Alabama at Birmingham, University of Pittsburgh Medical Center, Ochsner Health System, University of Texas Southwestern Medical Center, State University of New York - Downstate Medical Center, Newton-Wellesley Hospital, Baylor College of Medicine, City of Hope Medical Center, University of Florida, Northwell Health, H. Lee Moffitt Cancer Center and Research Institute, Vanderbilt University Medical Center, Ohio State University, Huntsman Cancer Institute, Columbia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The drugs, lenalidomide, bortezomib, and dexamethasone, are approved by the FDA. They have not been approved in the combination for multiple myeloma or any other type of cancer. Bortezomib is currently approved by the FDA for the treatment of multiple myeloma. Lenalidomide is approved for use with dexamethasone for patients with multiple myeloma who have received at least one prior therapy and for the treatment of certain types of myelodysplastic syndrome (another type of cancer affecting the blood). Dexamethasone is commonly used, either alone, or in combination with other drugs, to treat multiple myeloma. Please note that Bortezomib and Lenalidomide are provided to patients participating in this trial at no charge. Melphalan and cyclophosphamide, the drugs used during stem cell collection and transplant, are also approved by the FDA. Melphalan is an FDA-approved chemotherapy for multiple myeloma and is used as a high-dose conditioning treatment prior to stem cell transplantation. Cyclophosphamide is used, either alone, or in combination with other drugs, to treat multiple myeloma. These drugs have been used in other multiple myeloma studies and information from those studies suggests that this combination of therapy may help to treat newly diagnosed multiple myeloma. 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.
Detailed Description
After screening procedures determine if a patient is eligible for this research study, the patient will be randomized into one of the study groups: lenalidomide, bortezomib and dexamethasone without autologous stem cell transplantation, followed by lenalidomide maintenance (Arm A) or lenalidomide, bortezomib and dexamethasone with autologous stem cell transplantation, followed by lenalidomide maintenance (Arm B). There is an equal chance of being placed in either group. All participants will receive one cycle of lenalidomide, bortezomib and dexamethasone treatment before being randomized to Arm A or Arm B. Participants in Arm A will receive two additional cycles of lenalidomide, bortezomib and dexamethasone prior to stem cell collection. If randomized to Arm A, the subject will undergo stem cell collection, followed by five cycles of lenalidomide, bortezomib and dexamethasone. This will be followed by lenalidomide maintenance treatment until disease progression. Participants in Arm B will receive two additional cycles of lenalidomide, bortezomib and dexamethasone prior to stem cell collection. If randomized to Arm B, the subject will undergo stem cell collection and autologous stem cell transplantation, followed by two cycles of lenalidomide, bortezomib and dexamethasone. This will be followed by lenalidomide maintenance treatment until disease progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Lenalidomide, Bortezomib, Dexamethasone, Stem Cell Transplant, Myeloma, Multiple Myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Dose Treatment
Arm Type
Active Comparator
Arm Description
Lenalidomide, bortezomib, dexamethasone. Stem cell collection. Maintenance Lenalidomide.
Arm Title
High Dose Treatment with SCT
Arm Type
Experimental
Arm Description
Lenalidomide, bortezomib, dexamethasone. Stem cell collection. Autologous Stem Cell Transplant. Maintenance Lenalidomide.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
CC-5013
Intervention Description
Oral, 25 mg/day, days 1-14 for 8 total cycles for Arm A. Oral, 25 mg/day, days 1-14 for 5 total cycles for Arm B. Oral, 10-15 mg/day, daily for 12 months in maintenance for Arm A and Arm B.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
PS-341, Velcade
Intervention Description
IV, days 1, 4, 8 and 11 for 8 total cycles for Arm A. IV, days 1, 4, 8 and 11 for 5 total cycles for Arm B.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Oral, days 1, 2, 4, 5, 8, 9, 11 and 12 for 8 total cycles for Arm A. Oral, days 1, 2, 4, 5, 8, 9, 11 and 12 for 5 total cycles for Arm B. Dose of 20 mg/day for first 3 cycles. Dose of 10 mg/day for remaining cycles.
Intervention Type
Procedure
Intervention Name(s)
Autologous Stem Cell Transplant
Intervention Description
Stem cell transplant
Primary Outcome Measure Information:
Title
Primary Outcome
Description
To compare progression-free survival (PFS) between Arm A and Arm B.
Time Frame
Up to 6 years or until progression
Secondary Outcome Measure Information:
Title
Secondary Outcome
Description
To compare the response rates (RR) between the two arms.
Time Frame
Up to 6 years or until progression
Title
Secondary Outcome
Description
To compare time to progression (TTP) between the two arms.
Time Frame
Up to 6 years or until progression
Title
Secondary Outcome
Description
To compare the overall survival (OS) between the two arms.
Time Frame
Up to 6 years or until progression
Title
Secondary Outcome
Description
To compare toxicity between the two arms.
Time Frame
Up to 6 years or until progression
Title
Secondary Outcome
Description
To define genetic prognostic groups evaluated by gene expression profiling (GEP).
Time Frame
Up to 6 years or until progression
Title
Secondary Outcomes
Description
To examine the best treatment in each GEP-defined prognostic group.
Time Frame
Up to 6 years or until progression
Title
Secondary Outcome
Description
To compare quality of life (QOL) between the two arms.
Time Frame
Up to 6 years or until progression
Title
Secondary Outcome
Description
To collect medical resource utilization (MRU) information which may be used in economic evaluation models.
Time Frame
Up to 6 years or until progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Multiple Myeloma, according to the International Myeloma Foundation 2003 Diagnostic Criteria Documented symptomatic myeloma, with organ damage related to myeloma with laboratory assessments performed within 21 days of registration Myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains. ECOG performance status </= 2 Negative HIV blood test Voluntary written informed consent Exclusion Criteria: Pregnant or lactating female Prior systemic therapy for MM (localized radiotherapy allowed if at least 7 days before study entry, corticosteroids allowed if dose </= equivalent of 160 mg dexamethasone over 2 weeks) Primary amyloidosis (AL) or myeloma complicated by amylosis Receiving any other investigational agents Known brain metastases Poor tolerability or allergy to any of the study drugs or compounds of similar composition Platelet count <50,000/mm3, within 21 days of registration ANC <1,000 cells/mm3, within 21 days of registration Hemoglobin <8 g/dL, within 21 days of registration Hepatic impairment (>/= 1.5 x institutional ULN or AST (SGOT), ALT (SGPT), or alkaline phosphatase >2 x ULN). Patients with benign hyperbilirubinemia are eligible. Renal insufficiency (serum creatinine >2.0 mg/dl or creatinine clearance <50 ml/min, within 21 days of registration) Respiratory compromise (DLCO < 50%) Clinical signs of heart or coronary failure or LVEF < 40%. Myocardial infarction within 6 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conductive system abnormalities Intercurrent illness including, but not limited to ongoing or active severe infection, known infection with hepatitis B or C virus, poorly controlled diabetes, severe uncontrolled psychiatric disorder or psychiatric illness/social situations that would limit compliance with study requirements Previous history of another malignant condition except for basal cell carcinoma and stage I cervical cancer. If malignancy was experienced more than 2 years ago and confirmed as cured, these participants may be considered for the study on case by case basis with PI discussion. Inability to comply with an anti-thrombotic treatment regimen Peripheral neuropathy >/= Grade 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul G. Richardson, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Comprehensive Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California at San Diego
City
La Jolla
State/Province
California
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Mountain States Tumor Institute at St. Luke's Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Ochsner Foundation Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Eastern Maine Medical Center
City
Brewer
State/Province
Maine
ZIP/Postal Code
04412
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Cape Cod Healthcare
City
Hyannis
State/Province
Massachusetts
ZIP/Postal Code
02601
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
New Hampshire Oncology and Hematology
City
Concord
State/Province
New Hampshire
Country
United States
Facility Name
New Hampshire Oncology and Hematology
City
Hooksett
State/Province
New Hampshire
Country
United States
Facility Name
New Hampshire Oncology and Hematology
City
Laconia
State/Province
New Hampshire
Country
United States
Facility Name
State University of New York Downstate Medical Center
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
North Shore Long Island Jewish Health System
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health and Sciences
City
Portland
State/Province
Oregon
Country
United States
Facility Name
University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35660812
Citation
Richardson PG, Jacobus SJ, Weller EA, Hassoun H, Lonial S, Raje NS, Medvedova E, McCarthy PL, Libby EN, Voorhees PM, Orlowski RZ, Anderson LD Jr, Zonder JA, Milner CP, Gasparetto C, Agha ME, Khan AM, Hurd DD, Gowin K, Kamble RT, Jagannath S, Nathwani N, Alsina M, Cornell RF, Hashmi H, Campagnaro EL, Andreescu AC, Gentile T, Liedtke M, Godby KN, Cohen AD, Openshaw TH, Pasquini MC, Giralt SA, Kaufman JL, Yee AJ, Scott E, Torka P, Foley A, Fulciniti M, Hebert K, Samur MK, Masone K, Maglio ME, Zeytoonjian AA, Nadeem O, Schlossman RL, Laubach JP, Paba-Prada C, Ghobrial IM, Perrot A, Moreau P, Avet-Loiseau H, Attal M, Anderson KC, Munshi NC; DETERMINATION Investigators. Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma. N Engl J Med. 2022 Jul 14;387(2):132-147. doi: 10.1056/NEJMoa2204925. Epub 2022 Jun 5.
Results Reference
derived
PubMed Identifier
34549906
Citation
Parmar H, Vesole DH, Biran N. From VAD to VRD: Is Transplant Still Needed in the Upfront Setting of Myeloma? Cancer J. 2021 May-Jun 01;27(3):190-195. doi: 10.1097/PPO.0000000000000522.
Results Reference
derived

Learn more about this trial

Randomized Trial of Lenalidomide, Bortezomib, Dexamethasone vs High-Dose Treatment With SCT in MM Patients up to Age 65

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