Phase 1b/2: Isatuximab, Iberdomide, Bortezomib, Dexamethasone in Transplant Ineligible/Deferred Newly Diagnosed Myeloma (IsaIberVD)

A Phase 1b/2 Study of the Combination Isatuximab, Iberdomide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible or Not Intended for Upfront Transplant

This study is to evaluate the combination of isatuximab, iberdomide, bortezomib, and dexamethasone in newly diagnosed multiple myeloma participants who are transplant ineligible or not intended for upfront transplant.

The names of the study drugs used in this research study are:

isatuximab, iberdomide, bortezomib dexamethasone

Study Overview

• Status: Not yet recruiting
• Conditions: Newly Diagnosed Multiple Myeloma
• Intervention / Treatment: Drug: Isatuximab; Drug: Iberdomide; Drug: Bortezomib; Drug: Dexamethesone

Detailed Description

This is an open-label, Phase 1b/2, multicenter study which will enroll patients with newly diagnosed multiple myeloma (NDMM), who are transplant ineligible or deferred, to induction followed by maintenance therapy. Participants will be registered in HCC CTMS OnCore before receiving any study-specific treatment, and study treatment is expected to begin within 5 days after registration.

The study drugs used in this research include bortezomib, dexamethasone, isatuximab, and iberdomide (CC-220). The U.S. Food and Drug Administration (FDA) has approved bortezomib and dexamethasone for the initial treatment of multiple myeloma. The FDA has approved isatuximab for initial treatment of multiple myeloma in transplant ineligible patients and for myeloma that has returned after prior treatment. The FDA has not approved iberdomide (CC-220) for the treatment of multiple myeloma. The combination of these drugs, used as induction and maintenance therapy in this study, is considered investigational.

The research study procedures include: screening for eligibility, in-clinic visits, urine tests, questionnaires, PET scans, blood tests, electrocardiograms (ECGs), bone marrow aspiration and biopsy, biobanking, and pregnancy tests for participants who are able to become pregnant.

It is expected that about 88 people will take part in this study. Participants are classified and assigned treatment for induction based on baseline age 70 years status and myeloma frailty score and further assigned for maintenance based on baseline International Myeloma Working Group (IMWG)/International Myeloma Society (IMS) genomic risk classification.

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yuxin Liu, MD; Phone Number: 857-215-3056; Email: yuxin_liu@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
      • Principal Investigator: Yuxin Liu, MD
      • Contact: Yuxin Liu, MD; Phone Number: 617-632-3823; Email: yuxin_liu@dfci.harvard.edu
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center (BIDMC)
      • Principal Investigator: David Avigan, MD
      • Contact: Yuxin Liu, MD; Phone Number: 617-632-3823; Email: yuxin_liu@dfci.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female, 18 years of age or older
• Ability to understand and the willingness to sign a written informed consent document
• NDMM based on IMWG criteria with clonal bone marrow plasma cells >10% or biopsy proven bony or extramedullary disease/plasmacytoma (EMD) with any one or more CRAB-features or myeloma defining events (Rajkumar, 2024). (See Appendix G)
• Ineligible for ASCT as assessed by the treating physician or eligible but prefers and agrees to defer ASCT until after induction and maintenance therapy, upon progression or at a later time

• Measurable disease defined as at least one of the following:

  • Serum M-protein 0.5 g/dL
  • Urine M-protein 200 mg/24 hours
  • Serum FLC assay: involved FLC 10 mg/dL (100 mg/L) and an abnormal kappa to lambda FLC ratio (< 0.26 or > 1.65)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (See Appendix A)

• Screening Laboratory evaluations with the following parameters:

  • Absolute neutrophil count (ANC) ≥ 1,000 cells/dL (1.0 x 109/L)

    --- Note: Growth factor support is not permitted within 10 days, [14 days for pegfilgrastim], prior to the screening hematologic test.

  • Platelet count ≥ 75,000 cells/dL (75 x 109/L) (without transfusions required during the 3 days prior to the screening hematologic test)
  • Total Bilirubin ≤ 2 X upper limit of normal (ULN) (except patients with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
  • AST (SGOT) and ALT (SGPT) ≤ 3.0 x ULN
  • Calculated creatinine clearance (CrCl) 30ml/min (Appendix B)
  • Hemoglobin ≥ 8.0 g/dl (red blood cell (RBC) transfusions are permitted)
• Individuals of childbearing potential (IOCBP) must have 2 negative pregnancy tests before initiation of therapy, and agree to ongoing testing, based on the frequency outlined in the Pregnancy Prevention Plan (PPP) (See Appendix H)
• Sexually active IOCBP agree to use protocol-specified contraceptive methods, at least 28 days prior to starting study drug, while taking study drug, including interruptions in study drugs, and for at least 28 days after the last dose of study drug or males sexually active with IOCBP, (including those who have had a vasectomy), agree to use protocol specified contraceptive methods while taking study drug, including interruptions in study drug and for at least 28 days after the last dose of iberdomide, 5 months after isatuximab and 6 months after bortezomib, according to the PPP (See Appendix H)
• All patients (male and female with or without childbearing potential) agree to counseling according to the PPP and to abstain from donating blood products for at least 28 days after the last dose of iberdomide and abstain from donating semen or sperm while taking study drug and for at least 28 days after the last dose of iberdomide according to the PPP (See Appendix H) and for 5 months after the last dose of isatuximab and 6 months after the last dose of bortezomib
• Must be able to take antithrombotic prophylaxis (See Section 5.9.1)

Exclusion Criteria:

• Prior therapy for MM. Patients may have received:

  • Corticosteroids for management of MM not to exceed equivalent of 160 mg of dexamethasone in a 2-week period and should be stable 7 days prior to the registration.
  • Focal palliative radiation for the management of bone pain completed ≥ 7 days prior to registration

  • Treatment for smoldering myeloma as long as the prior treatment did not include anti-CD38 therapy:

    • Patients with a prior history of serious allergic reactions associated with thalidomide, lenalidomide, or pomalidomide should not receive iberdomide as they could be at higher risk of hypersensitivity.
    • Resolution of symptoms of prior treatment to ≤ grade 1 or baseline
• Known intolerance to steroid therapy
• Prior history of malignancies, other than MM, will be excluded unless the participant has been free of the disease for ≥ 3 years with the exception of the following non-invasive malignancies: basal or squamous cell skin carcinoma, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological findings of prostate cancer (T1a or T1b using the Tumor, Node, Metastasis (TNM) clinical staging system), or prostate cancer that is curative
• Central nervous system involvement with MM
• Peripheral neuropathy grade 3, or grade 2 with pain on clinical exam during screening period
• Any medical or psychiatric illness that in the investigator's opinion would impose excessive risk to the patient or would adversely affect participation
• Concurrent uncontrolled cardiovascular conditions (uncontrolled hypertension, uncontrolled arrhythmias, congestive heart failure, unstable angina, grade 3 thromboembolic event or myocardial infarction) in the past 6 months
• Concurrent symptomatic amyloidosis or plasma cell leukemia
• POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
• Seropositive for human immunodeficiency virus (HIV-1), chronic or active hepatitis B (defined as positive hepatitis B surface antigen (HepBSAg) or Hepatitis B core antibody (HepBcore Ab) or C (Hep C Ab), or acute hepatitis A. If any history of exposure to hepatitis B or C, then PCR should be negative
• Pregnant or breast feeding female or IOCBP who intend to become pregnant during the study.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A Induction: Age <70 years and Fit (standard-intensity schedule); Participants <70 years of age and considered fit based on the myeloma frailty score of 0. Induction cycles 1-8; 28-day cycles: Isatuximab: 10 mg/kg Intravenous (IV) Days 1, 8, 15, 22 (Cycle 1 only); Days 1,15 (Cycle 2+) Iberdomide: 1 mg or 0.75 mg Oral (PO) Days 1-21 Bortezomib: 1.3 mg/m2 Subcutaneous (SC) Days 1, 8, 15, 22 Dexamethasone: 20 mg IV or PO Days 1, 2, 8, 9, 15, 16, 22, 23	Drug: Isatuximab; Administration, pre-medications and supportive care per protocol; Other Names: Sarclisa; Isatuximab-irfc; Drug: Iberdomide; Administration, pre-medications and supportive care per protocol; Other Names: CC-220; Drug: Bortezomib; Administration, pre-medications and supportive care per protocol; Other Names: Velcade; PS-341; Drug: Dexamethesone; Administration, pre-medications and supportive care per protocol; Other Names: Decadron
Experimental: Group B Induction: Age ≥70 years and/or Intermediate Fit/Frail (reduced-intensity schedule); Participants ≥70 years of age and/or considered intermediate fitness and frail based on the myeloma frailty score of >1. Induction cycles 1-8; 28-day cycles: Isatuximab: 10 mg/kg IV Days 1, 8, 15, 22 (Cycle 1 only); Days 1,15 (Cycle 2+) Iberdomide: 1 mg or 0.75 mg PO Days 1-21 Bortezomib: 1.3 mg/m2 SC Days 1, 8, 15 Dexamethasone: 12 mg IV or PO Days 1, 8, 15, 22; 8 mg IV or PO Days 2, 9, 16, 23	Drug: Isatuximab; Administration, pre-medications and supportive care per protocol; Other Names: Sarclisa; Isatuximab-irfc; Drug: Iberdomide; Administration, pre-medications and supportive care per protocol; Other Names: CC-220; Drug: Bortezomib; Administration, pre-medications and supportive care per protocol; Other Names: Velcade; PS-341; Drug: Dexamethesone; Administration, pre-medications and supportive care per protocol; Other Names: Decadron
Experimental: Group A Maintenance: High-Risk, Age <70 years and Fit (3-drug schedule); Participants high-risk per IMWG/IMS criteria, <70 years of age, considered fit based on the myeloma frailty score of 0. Maintenance cycles 1-36; 28-day cycles: (for participants with ≥PR after Induction Cycle 8) Isatuximab: 10 mg/kg IV Days 1, 15 Iberdomide: 1 mg or 0.75 mg PO Days 1-21 Bortezomib: 1.3 mg/m2 SC Days 1, 15	Drug: Isatuximab; Administration, pre-medications and supportive care per protocol; Other Names: Sarclisa; Isatuximab-irfc; Drug: Iberdomide; Administration, pre-medications and supportive care per protocol; Other Names: CC-220; Drug: Bortezomib; Administration, pre-medications and supportive care per protocol; Other Names: Velcade; PS-341
Experimental: Group A Maintenance: Standard-Risk, Age <70 years and Fit (2-drug schedule); Participants standard-risk per IMWG/IMS criteria, <70 years of age, considered fit based on the myeloma frailty score of 0. Maintenance cycles 1-36; 28-day cycles: (for participants with ≥PR after Induction Cycle 8) Isatuximab: 10 mg/kg IV Days 1, 15 Iberdomide: 1 mg or 0.75 mg PO Days 1-21	Drug: Isatuximab; Administration, pre-medications and supportive care per protocol; Other Names: Sarclisa; Isatuximab-irfc; Drug: Iberdomide; Administration, pre-medications and supportive care per protocol; Other Names: CC-220
Experimental: Group B Maintenance: High-Risk, Age ≥70 years and/or Intermediate Fit/Frail (3-drug schedule); Participants high-risk per IMWG/IMS criteria, ≥70 years of age and/or considered intermediate fitness and frail based on the myeloma frailty score of >1. Maintenance cycles 1-36; 28-day cycles: (for participants with ≥PR after Induction Cycle 8) Isatuximab: 10 mg/kg IV Days 1, 15 Iberdomide: 1 mg or 0.75 mg PO Days 1-21 Bortezomib: 1.3 mg/m2 SC Days 1, 15	Drug: Isatuximab; Administration, pre-medications and supportive care per protocol; Other Names: Sarclisa; Isatuximab-irfc; Drug: Iberdomide; Administration, pre-medications and supportive care per protocol; Other Names: CC-220; Drug: Bortezomib; Administration, pre-medications and supportive care per protocol; Other Names: Velcade; PS-341
Experimental: Group B Maintenance: Standard-Risk, Age ≥70 years and/or Intermediate Fit/Frail (2-drug schedule); Participants standard-risk per IMWG/IMS criteria, ≥70 years of age and/or considered intermediate fitness and frail based on the myeloma frailty score of >1. Maintenance cycles 1-36; 28-day cycles: (for participants with ≥PR after Induction Cycle 8) Isatuximab: 10 mg/kg IV Days 1, 15 Iberdomide: 1 mg or 0.75 mg PO Days 1-21	Drug: Isatuximab; Administration, pre-medications and supportive care per protocol; Other Names: Sarclisa; Isatuximab-irfc; Drug: Iberdomide; Administration, pre-medications and supportive care per protocol; Other Names: CC-220

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting Toxicities (DLT) by Age-Frailty Group [Phase Ib]	DLT is defined as any adverse event (AE) that (a) is at least possibly related to study treatment, (b) occur during cycle 1, and (c) meets the following criteria: Hematologic - grade 4 neutropenia lasting >5 days despite supportive care (G-CSF allowed), grade ≥3 febrile neutropenia, grade 3 thrombocytopenia with clinically significant bleeding, grade 4 thrombocytopenia unless clearly attributable to underlying disease, and any grade 5 AE; Non-Hematologic - any grade ≥3 AE (except alopecia), uncontrolled nausea, vomiting, or diarrhea not resolving to ≤ grade 1 with medical management, due to toxicity interruption of >4 doses of iberdomide or >1 dose of isatuximab or bortezomib (infusion-related reactions excluded), due to toxicity inability to initiate cycle 2 day 1 within 7 days.	Assessed continuously during induction cycle 1, up to day 28 + 30 days
Recommended Phase II Dose (RP2D) of Iberdomide by Age-Frailty Group [Phase Ib]	The RP2D of iberdomide in combination with fixed doses of isatuximab, bortezomib and dexamethasone is determined by the number of participants experiencing DLT. There are two potential iberdomide dose levels under evaluation including one de-escalation dose. The RP2D is defined as the highest dose at which fewer than 2 of 6 patients experience a DLT.	Assessed continuously during induction cycle 1, up to day 28 + 30 days
Complete Response (CR) or Better Rate by Age-Frailty Group [Phase II]	CR or better rate is defined as the proportion of participants who achieve a complete response (CR) or stringent CR (sCR) during induction therapy, according to the International Myeloma Working Group Uniform Response Criteria (IMWG-URC).	Assessed on day 1 of each cycle over 8 induction cycles (cycle duration=4 weeks), up to 32 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction Grade 3 or 4 Treatment-Related Adverse Event (TRAE) Rate by Age-Frailty Group [Phase Ib]	Induction grade 3 or 4 TRAE rate is defined as the proportion of participants who experience a grade 3 or 4 AE based on Common Toxicity Criteria for Adverse Events version 5 (CTCAEv5) with a treatment attribution of possible, probable or definite during induction.	Assessed continuously during induction cycles 1-8 (cycle duration=4 weeks), up to 32 weeks + 30 days.
Induction Feasibility Rate by Age-Frailty Group [Phase II]	Induction feasibility rate is defined as the proportion of participants completing 8 cycles of induction and receiving at least one dose of maintenance treatment.	Assessed after induction cycle 8 (cycle duration=4 weeks), at 32 weeks plus 30 days.
Induction Grade 3 or 4 TRAE Rate by Age-Frailty Group [Phase II]	Induction grade 3 or 4 TRAE rate is defined as the proportion of participants who experience a grade 3 or 4 AE based on CTCAEv5 with a treatment attribution of possible, probable or definite during induction.	Assessed continuously during induction cycles 1-8 (cycle duration=4 weeks), up to 32 weeks + 30 days.
Maintenance Grade 3 or 4 TRAE Rate by Age-Frailty Risk Group [Phase II]	Maintenance grade 3 or 4 TRAE rate is defined as the proportion of participants who experience a grade 3 or 4 AE based on CTCAEv5 with a treatment attribution of possible, probable or definite during maintenance.	Assessed continuously during maintenance cycles 1-36 (cycle duration=4 weeks), up to 144 weeks + 30 days.
Induction Serious Adverse Event (SAE) Rate by Age-Frailty Group [Phase II]	Induction SAE is any untoward medical occurrence at any dose during induction that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization (excluding planned hospitalizations), results in persistent or significant disability or incapacity (namely a substantial disruption of normal life functions), is a congenital anomaly or birth defect, or is considered a medically important event.	Assessed continuously during induction cycles 1-8 (cycle duration=4 weeks), up to 32 weeks + 30 days.
Maintenance SAE Rate by Age-Frailty Risk Group [Phase II]	Maintenance SAE is any untoward medical occurrence at any dose during maintenance that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization (excluding planned hospitalizations), results in persistent or significant disability or incapacity (namely a substantial disruption of normal life functions), is a congenital anomaly or birth defect, or is considered a medically important event.	Assessed continuously during maintenance cycles 1-36 (cycle duration=4 weeks), up to 144 weeks + 30 days.
Induction Best Response by Age-Frailty Group [Phase II]	Best response over induction will be assessed according to the IMWG-URC including sCR, CR, VGPR, PR, MR, SD or PD.	Assessed day 1 of each cycle during induction cycles 1-8 (cycle duration=4 weeks), up to 32 weeks.
Maintenance Best Response by Age-Frailty Risk Group [Phase II]	Best response over maintenance will be assessed according to the IMWG-URC including sCR, CR, VGPR, PR, MR, SD or PD.	Assessed day 1 of each cycle during maintenance cycles 1-36 (cycle duration=4 weeks), up to 144 weeks.
Induction Minimal Residual Disease (MRD) Negativity Rate by Age-Frailty Group [Phase II]	Induction MRD-negative rate is defined as the proportion of participants achieving MRD negativity, as assessed by next-generation sequencing (NGS) or next-generation flow cytometry (NGF) with sensitivity of >1 in 10-5 nucleated cells, according to the IMWG-URC.	Assessed after induction cycle 8 (cycle duration=4 weeks), at 32 weeks.

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Yuxin Liu, MD, Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6.
• Palumbo A, Bringhen S, Mateos MV, Larocca A, Facon T, Kumar SK, Offidani M, McCarthy P, Evangelista A, Lonial S, Zweegman S, Musto P, Terpos E, Belch A, Hajek R, Ludwig H, Stewart AK, Moreau P, Anderson K, Einsele H, Durie BG, Dimopoulos MA, Landgren O, San Miguel JF, Richardson P, Sonneveld P, Rajkumar SV. Geriatric assessment predicts survival and toxicities in elderly myeloma patients: an International Myeloma Working Group report. Blood. 2015 Mar 26;125(13):2068-74. doi: 10.1182/blood-2014-12-615187. Epub 2015 Jan 27.
• Avet-Loiseau H, Davies FE, Samur MK, Corre J, D'Agostino M, Kaiser MF, Raab MS, Weinhold N, Gutierrez NC, Paiva B, Neri P, Weisel K, Maura F, Walker BA, Bustoros M, Stewart AK, Usmani SZ, Hillengass J, Chng WJ, Keats JJ, Martinez-Lopez J, Sperling AS, Touzeau C, Zhan F, Raje NS, Cavo M, Bolli N, Ghobrial IM, Dhodapkar MV, Jagannath S, Spencer A, Parekh S, Bahlis NJ, Lonial S, Sonneveld P, Bergsagel L, Orlowski RZ, Morgan G, Mateos MV, Rajkumar SV, San Miguel JF, Anderson KC, Moreau P, Kumar S, Prosper F, Munshi NC. International Myeloma Society/International Myeloma Working Group Consensus Recommendations on the Definition of High-Risk Multiple Myeloma. J Clin Oncol. 2025 Aug 20;43(24):2739-2751. doi: 10.1200/JCO-24-01893. Epub 2025 Jun 9.

Study record dates

Study Major Dates

• Study Start (Estimated): June 26, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2034

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: multiple myeloma; newly diagnosed multiple myeloma
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Inorganic Chemicals; Benzene Derivatives; Sulfonic Acids; Sulfur Acids; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Benzenesulfonates; Arylsulfonates; Arylsulfonic Acids; Bortezomib; Calcium Dobesilate; iberdomide; isatuximab
• Other Study ID Numbers: 25-854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No