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

• ClinicalTrials.gov Identifier: NCT01208662
• Recruitment Status: Active, not recruiting
• First Posted: September 24, 2010
• Results First Posted: December 18, 2023
• Last Update Posted: December 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
• Information provided by (Responsible Party): Paul Richardson, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: September 23, 2010
• First Posted Date: September 24, 2010
• Results First Submitted Date: October 2, 2023
• Results First Posted Date: December 18, 2023
• Last Update Posted Date: December 18, 2023
• Actual Study Start Date: October 2010
• Actual Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 27, 2023)

Median Progression-Free Survival (PFS) [ Time Frame: On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median (maximum) PFS follow-up was 70 and 129 months. ]

PFS was estimated using the Kaplan-Meier (KM) method and defined as time from randomization to the earlier of disease progression (PD) as determined by central review or death from any cause (events). Patients who started non-protocol therapy (NPT) were censored at the date of NPT initiation if available or date treatment ended if date of NPT was missing. Deaths occurring beyond 1 year from the date last known progression-free are not counted as events and censored at date of last disease evaluation. Patients who had not started NPT, progressed, or died were censored at the date of last disease evaluation. PD was based upon the International Myeloma Working Group (IMWG) uniform response criteria. [Kumar S, et al Lancet Oncol 2016;17(8):e328-e346].

Original Primary Outcome Measures (submitted: September 23, 2010)

Primary Outcome [ Time Frame: Up to 6 years or until progression ]

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

Current Secondary Outcome Measures (submitted: November 27, 2023)

• Partial Response (PR) Rate [ Time Frame: Disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 133.5 months in this study cohort. ]
  The PR rate is the percentage of participants achieving PR or better on treatment and was evaluated based on the IMWG criteria. PR was defined as > 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by > 90% or to < 200mg per 24 hours. If the serum and urine M-protein are unmeasurable, a > 50% decrease in the difference between involved and uninvolved free light chain levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, >50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was > 30%. In addition to the above listed criteria, if present at baseline, a > 50% reduction in the size of soft tissue plasmacytomas was also required. Exact (Clopper-Pearson) confidence limits of 98.2857% represents Bonferroni adjustment for 7 tests (1-0.05/7) per statistical analysis plan for key secondary outcomes.
• Very Good Partial Response (VGPR) Rate [ Time Frame: Disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 134 months in this study cohort. ]
  The VGPR rate is the percentage of participants achieving VGPR or better on treatment and was evaluated based on IMWG criteria. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 hours.
• Complete Response (CR) Rate [ Time Frame: Disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 134 months in this study cohort. ]
  The CR rate is the percentage of participants achieving CR or better on treatment and was evaluated based on IMWG criteria. CR was defined as the negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. Confirmation with repeat bone marrow biopsy was not needed.
• Median Duration of Response: Partial Response (DOR PR) [ Time Frame: On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median (maximum) DOR PR follow-up was 62.9 and 122.9 months. ]
  DOR PR was estimated using the KM method and defined as the time from documented best response as CR to documented disease progression per IMWG criteria. Patients who have not progressed or died were censored at the date last known progression-free.
• 5-Year Time to Progression (TTP) [ Time Frame: On treatment, disease was assessed every cycle up to maintenance and every 3 cycles on maintenance. In long-term follow-up, disease was assessed every 2 months until PD or death. Median TTP follow-up was 70 months. The probability estimate is at 5 years. ]
  TTP was estimated using the KM method and defined as time from randomization to time of documented IMWG disease progression or censoring time (time of last disease evaluation for those alive, time to death among those who died). Patients initiating non-protocol therapy prior to progression or death were censored at the date of non-protocol therapy in the TTP analysis. The 5-year TTP endpoint is a probability.
• 5-Year Overall Survival (OS) [ Time Frame: In long-term follow-up, survival follow-up every 2 months until death. Median (maximum) OS follow-up was 76 and 129 months.The probability estimate is at 5 years. ]
  OS was estimated using the KM method and defined as time from randomization to death due to any cause. Patients alive were censored at date last known alive. The 5-year OS endpoint is a probability.
• Grade 3 or Higher Treatment-Related Non-Hematologic Adverse Event (AE) Rate [ Time Frame: AEs was assessed every cycle on treatment. Median treatment duration (months) from randomization 28.2 (RVD Alone) and 36.1 (RVD plus ASCT). Maximum treatment duration was 133.5 months in this study cohort. ]
  Safety was evaluated throughout trial treatment, including ASCT, and through 30 days after receipt of the last dose of a trial drug. Treatment attribution and grade were based on the NCI CTCAE v4. The Grade 3 or Higher Treatment-Related Non-Hematologic AE Rate is percentage of participants who experienced any grade 3-5 treatment-related (possible, probable or definite attribution) non-hematologic adverse event based on CTCAEv4 as reported on case report forms. The difference in the rate of all grade 3 or higher toxicities was compared between the two groups using Fisher's exact test.
• 5-year Cumulative Incidence of Second Primary Malignancy (SPM) [ Time Frame: 5 years ]
  Second primary malignancy (SPM) is defined as the development of another new, unrelated cancer, regardless of treatment for previous malignancy attribution. The cumulative incidence of SPMs was estimated with death as a competing risk. SPMs were collected using an SAE form or MEDWATCH 3500A form, with intensity determined by using the NCI CTCAE version 4 as a guideline.
• Median Treatment Duration [ Time Frame: Up to 134 months ]
  Treatment duration estimated using the KM method is defined as the time from registration (C1) to the time off treatment (event) or censored at date of last treatment.
• Median Maintenance Treatment Duration [ Time Frame: Up to 128 months ]
  Maintenance treatment duration estimated using the KM method is defined as the time from start of maintenance to the time off maintenance (event) or censored at date of last maintenance treatment.
• Subsequent Therapy Rate [ Time Frame: Up to 129 months ]
  Subsequent therapy rate was the percentage of participants who discontinued treatment and initiated subsequent non-protocol therapy.
• Change From Baseline on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) [ Time Frame: Cycle 1 (Baseline), Cycle 2, Pre-Mobilization, Cycle 5 Arm A / Post Auto-HSCT Arm B, Cycle 8 Arm A /Cycle 5 Arm B, Maintenance Day 1, 2 years from baseline, 3 years from baseline ]
  The FACT/GOG-NTX assessment consists of 11 questions that are all used to construct 1 subscale to summarize symptoms of peripheral neuropathy, including sensory, motor, and auditory problems and cold sensitivity. (https://www.facit.org/measures/FACT-GOG-NTX) Each question has 4 possible responses from 0 (Not at all) to 4 (Very Much) which are reverse-scored and summed. This sum is then scaled by the number of questions answered by multiplying by 11 and then dividing by the number of questions that are non-blank, in order to keep all final scores proportional to one another even if some questions are left blank. The aggregate score ranges from 0 to 44, with higher scores indicating less neurotoxicity and lower scores indicating more neurotoxicity. Change from baseline is the difference
• Change From Baseline on the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30): Global Health Status/Quality of Life (QoL) Sub-scale [ Time Frame: Cycle 1 (Baseline), Cycle 2, Pre-Mobilization, Cycle 5 Arm A / Post Auto-HSCT Arm B, Cycle 8 Arm A /Cycle 5 Arm B, Maintenance Day 1, 2 years from baseline, 3 years from baseline ]
  The EORTC QLQ-C30 assessment consists of 30 questions that are used to construct 15 distinct sub-scales (five function scales, nine symptom scales, and a global health status/QoL scale). The global health status/QoL scale is comprised of two questions each with a range of 6 (1=Very Poor to 7=Excellent). Scores on all sub-scales range from 0 to 100 after linear transformation of the raw scores, with higher scores representing better global health status and quality of life.
• Quality-Adjusted Life Years (QALYs) [ Time Frame: Maximum observation of survival for this study cohort was 129.4 months. ]
  QALYs were estimated with a model beginning at initiation of first-line therapy by arm. A lifetime horizon, as well as subsequent lines of therapy, was examined using open-source Amua 0.3.0 software. Base case analysis was performed using 10,000 first-order Monte Carlo simulations. Conditional probabilities were extracted from Kaplan-Meier curves from pivotal clinical trials using WebPlotDigitizer. Costs were estimated from RED BOOK and DFCI charge reporting in US Dollars ($) after inflation adjustment to 2022 and 3% discounting, and QALYs effects were measured using EQ-5D data from Hatswell et al.

Original Secondary Outcome Measures (submitted: September 23, 2010)

• Secondary Outcome [ Time Frame: Up to 6 years or until progression ]
  To compare the response rates (RR) between the two arms.
• Secondary Outcome [ Time Frame: Up to 6 years or until progression ]
  To compare time to progression (TTP) between the two arms.
• Secondary Outcome [ Time Frame: Up to 6 years or until progression ]
  To compare the overall survival (OS) between the two arms.
• Secondary Outcome [ Time Frame: Up to 6 years or until progression ]
  To compare toxicity between the two arms.
• Secondary Outcome [ Time Frame: Up to 6 years or until progression ]
  To define genetic prognostic groups evaluateed by gene expression profiling (GEP).
• Secondary Outcomes [ Time Frame: Up to 6 years or until progression ]
  To examine the best treatment in each GEP-defined prognostic group.
• Secondary Outcome [ Time Frame: Up to 6 years or until progression ]
  To compare quality of life (QOL) between the two arms.
• Secondary Outcome [ Time Frame: Up to 6 years or until progression ]
  To collect medical resource utilization (MRU) information which may be used in economic evaluation models.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

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. Randomization was stratified by International Staging System (ISS) disease stage (I, II, or III) and cytogenetics (high-risk [presence of 17p deletion, t(4;14), or t(14;16) on fluorescence in-situ hybridization], standard-risk [absence of high-risk abnormalities], or undetermined [test failure]) assessed locally in a screening bone marrow sample, with positivity cut-offs per institutional standards.

• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Multiple Myeloma

Intervention

• Drug: Lenalidomide
  oral administration
  Other Name: CC-5013
• Drug: Bortezomib
  intravenous or, following protocol amendment, subcutaneous administration
  Other Names:

  • PS-341
  • Velcade
• Drug: Dexamethasone

  oral administration

  Dose of 20 mg/day for first 3 cycles. Dose of 10 mg/day for remaining cycles.

  Other Name: Decadron
• Procedure: Autologous Stem Cell Transplant
  Autologous refers to stem cells that are harvested from the participant to be a source of new blood cells after high-dose chemotherapy with melphalan.
  Other Name: Peripheral Blood Stem Cell (PBSC) Transplant

Study Arms

• Experimental: RVD Alone

  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

  Interventions:

  • Drug: Lenalidomide
  • Drug: Bortezomib
  • Drug: Dexamethasone
• Active Comparator: RVD plus ASCT

  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

  Interventions:

  • Drug: Lenalidomide
  • Drug: Bortezomib
  • Drug: Dexamethasone
  • Procedure: Autologous Stem Cell Transplant

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: November 27, 2023): 729
• Original Estimated Enrollment (submitted: September 23, 2010): 1000
• Estimated Study Completion Date: September 2025
• Actual Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States
• Removed Location Countries: France

Administrative Information

• NCT Number: NCT01208662
• Other Study ID Numbers: 10-106
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Paul Richardson, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Paul Richardson, MD, Dana-Farber Cancer Institute
• Current Study Sponsor: Paul Richardson, MD
• Original Study Sponsor: Dana-Farber Cancer Institute

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

Investigators

• Principal Investigator: Paul G. Richardson, MD; Dana-Farber Cancer Institute

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: October 2023