Cristina Gasparetto

Overview:

Dr. Gasparetto performs both laboratory and clinical research in the field of multiple myeloma. Her primary research interests are in developing immunotherapy approaches to treating multiple myeloma particularly in conjunction with hematopoietic stem cell transplantation. Ongoing laboratory research projects include the development of dendritic cell vaccines and antibody therapies. Clinical studies include a recently approved trial involving vaccination with autologous dendritic cells pulsed with idiotypic protein following high dose chemotherapy and autologous peripheral blood stem cells transplant. Upcoming trials include novel antibody therapies for multiple myeloma. Dr. Gasparetto is also an investigator on several other clinical trials for myeloma including non-myeloablative allogeneic transplantation, high dose sequential chemotherapy and autologous peripheral blood stem cell transplantation and transplantation of partially HLA matched unrelated cord blood.

Positions:

Professor of Medicine

Medicine, Hematologic Malignancies and Cellular Therapy
School of Medicine

Member of the Duke Cancer Institute

Duke Cancer Institute
School of Medicine

Education:

M.D. 1986

Sapienza University of Rome (Italy)

Medical Resident, Medicine

Duke University

Fellow in Hematology/Oncology, Medicine

Duke University

Grants:

Dendritic Cell Based Vaccination for Multiple Myeloma

Administered By
Medicine, Hematologic Malignancies and Cellular Therapy
Awarded By
National Institutes of Health
Role
Principal Investigator
Start Date
End Date

A Phase 2, Open-label, Multicenter, Dose-Escalation and Expansion Study of Venetoclax in Combination with Pomalidomide and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma

Administered By
Duke Cancer Institute
Awarded By
AbbVie Inc.
Role
Principal Investigator
Start Date
End Date

A Phase 1/2, Multicenter, Dose-Escalation and Expansion Study of Combination Therapy with Venetoclax, Daratumumab and Dexamethasone (with and without Bortezomib) in Subjects with Relapsed or Refractory Multiple Myeloma

Administered By
Duke Cancer Institute
Awarded By
AbbVie Inc.
Role
Principal Investigator
Start Date
End Date

Open-Label, Multicenter, Dose-Escalation Expansion Phase IB study to Evaluate Safety, Pharmacokinetics, and activity of BET Inhibitor RO6870810, Given as Mono- and combination Therapy to patients with Advanced Multiple Myeloma

Administered By
Duke Cancer Institute
Awarded By
F. Hoffmann-La Roche Ltd
Role
Principal Investigator
Start Date
End Date

A Phase 1, Open Label Study to evaluate the safety Pharmacokinetic, Pharmacodynamic and clinical activity of PF-06863135, A B-Cell Maturation Antigen (BCMA)- CD3 Bispecifi Antibody In Patient

Administered By
Duke Cancer Institute
Awarded By
Pfizer, Inc.
Role
Principal Investigator
Start Date
End Date

Publications:

Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma.

This phase 2 study evaluated isatuximab as monotherapy or combined with dexamethasone in relapsed/refractory multiple myeloma (RRMM). Patients had RRMM refractory to an immunomodulatory drug (IMiD) and a proteasome inhibitor (PI) or had received ≥3 prior lines of therapy incorporating an IMiD and PI. Patients received isatuximab either as monotherapy (20 mg/kg on days 1, 8, 15, and 22 [once weekly] of cycle 1 followed by 20 mg/kg on days 1 and 15 of subsequent cycles; Isa group) or in combination with dexamethasone (40 mg/d [20 mg/d in patients aged ≥75 years] once weekly; Isa-dex group). Treated patients (N = 164) had received a median of 4 (range, 2-10) prior treatment lines. Patients received a median of 5 (1-24) and 7 (1-22) treatment cycles; at data cutoff, 13 (11.9%) of 109 and 15 (27.3%) of 55 patients remained on treatment in the Isa and Isa-dex arms, respectively. Overall response rate (primary efficacy end point) was 23.9% in the Isa arm and 43.6% in the Isa-dex arm (odds ratio, 0.405; 95% confidence interval, 0.192-0.859; P = .008). Median progression-free survival and overall survival were 4.9 and 18.9 months for Isa, and 10.2 and 17.3 months for Isa-dex. Infusion reactions (mostly grade 1/2) and hematologic abnormalities were the most common adverse events. There was a similar incidence of grade 3 or higher infections in both groups (22.0% and 21.8%). In conclusion, addition of dexamethasone to isatuximab increased response rates and survival outcomes with no detrimental effect on safety. This trial was registered at www.clinicaltrials.gov as #NCT01084252.
Authors
Dimopoulos, M; Bringhen, S; Anttila, P; Capra, M; Cavo, M; Cole, C; Gasparetto, C; Hungria, V; Jenner, M; Vorobyev, V; Ruiz, EY; Yin, JY; Saleem, R; Hellet, M; Macé, S; Paiva, B; Vij, R
MLA Citation
Dimopoulos, Meletios, et al. “Isatuximab as monotherapy and combined with dexamethasone in patients with relapsed/refractory multiple myeloma.Blood, vol. 137, no. 9, Mar. 2021, pp. 1154–65. Pubmed, doi:10.1182/blood.2020008209.
URI
https://scholars.duke.edu/individual/pub1463047
PMID
33080623
Source
pubmed
Published In
Blood
Volume
137
Published Date
Start Page
1154
End Page
1165
DOI
10.1182/blood.2020008209

Treatment Patterns and Outcomes in Elderly Patients with Newly Diagnosed Multiple Myeloma: Results from the Connect® MM Registry

<jats:p>Background: Multiple myeloma (MM) is common among the elderly, with 35% of patients (pts) diagnosed being aged ≥75 years (y). With increasing overall life expectancy, the incidence and prevalence of newly diagnosed and previously treated MM patients ≥80 y is expected to increase over time. Because elderly pts are often excluded from clinical trials, data focused on their treatment patterns and clinical outcomes are lacking. The Connect® MM Registry (NCT01081028) is a large, US, multicenter, prospective observational cohort study of pts with newly diagnosed MM (NDMM) designed to examine real-world diagnostic patterns, treatment patterns, clinical outcomes, and health-related quality of life patient-reported outcomes. This analysis reviews treatment patterns and outcomes in elderly pts from the Connect MM Registry.</jats:p> <jats:p>Methods: Pts enrolled in the Connect MM registry at 250 community, academic, and government sites were included in this analysis. Eligible pts were adults aged ≥18 y with symptomatic MM diagnosed ≤2 months before enrollment, as defined by International Myeloma Working Group criteria; no exclusion criteria were applied. For this analysis, pts were categorized into 4 age groups: &lt;65, 65 to 74, 75 to 84, and ≥85 y. Pts were followed from time of enrollment to the earliest of disease progression (or death), loss to follow-up, or data cutoff date of February 7, 2019. Descriptive statistics were used for baseline characteristics and treatment regimens. Survival outcomes were analyzed using Cox regression. Time to progression (TTP) analysis excluded causes of death not related to MM.</jats:p> <jats:p>Results: Of 3011 pts enrolled (median age 67 y), 132 (4%) were aged ≥85 y, and 615 (20%) were aged 75-84 y at baseline. More pts aged ≥85 y had poor prognostic factors such as ISS stage III disease and reduced hemoglobin (&lt;10 g/dL or &gt;2 g/dL &lt;LLN) compared with other age groups, although no notable differences between creatinine and calcium levels were observed across age groups (Table). A lower proportion of elderly pts (75-84 and ≥85 y) received triplet regimens as frontline therapy. More elderly pts received a single novel agent, whereas use of 2 novel agents was more common in younger pts (Table). The most common frontline regimens among elderly pts were bortezomib (V) + dexamethasone (D), followed by lenalidomide (R) + D, whereas those among younger pts included RVD, followed by VD and CyBorD (Table). No pt aged ≥85 y, and 4% of pts aged 75-84 y received high-dose chemotherapy and autologous stem cell transplant (vs 61% in the &lt;65 y and 37% in the 65-74 y age group). The most common maintenance therapy was RD in pts ≥85 y (although the use was low) and R alone in other age groups (Table). In the ≥85 y group, 27%, 10%, and 4% of pts entered 2L, 3L, and 4L treatments respectively, vs 43%, 23%, and 13% in the &lt;65 y group.</jats:p> <jats:p>Progression-free survival was significantly shorter in the ≥85 y age group vs the 75-84 y age group (P=0.003), 65-74 y age group (P&lt;0.001), and &lt;65 y age group (P&lt;0.001; Fig.1). TTP was significantly shorter in the ≥85 y group vs the &lt;65 y group (P=0.020); however, TTP was similar among the 65-74 y, 75-84 y, and ≥85 y cohorts (Fig. 2). Overall survival was significantly shorter in the ≥85 y group vs the 75-84 y, 65-74 y, and &lt;65 y groups (all P&lt;0.001; Fig. 3). The mortality rate was lowest (46%) during first-line treatment (1L) in pts aged ≥85 y (mainly attributed to MM progression) and increased in 2L and 3L (47% and 54%, respectively); a similar trend was observed in the younger age groups. The main cause of death was MM progression (29% in the ≥85 y vs 16% in the &lt;65 y group). Other notable causes of death in the ≥85 y group included cardiac failure (5% vs 2% in &lt;65 y group) and pneumonia (5% vs 1% in &lt;65 y group).</jats:p> <jats:p>Conclusions: In this analysis, elderly pts received similar types of frontline and maintenance regimens as younger pts, although proportions varied with decreased use of triplet regimens with age. Considering similarities in TTP across the 65-74 y, 75-84 y, and ≥85 y cohorts, these real-world data support active treatment and aggressive supportive care of elderly symptomatic pts, including with novel agents. Additionally, further clinical studies specific to elderly patients with MM should be explored.</jats:p> <jats:p /> <jats:sec> <jats:title>Disclosures</jats:title> <jats:p>Lee: Amgen: Consultancy, Research Funding; GlaxoSmithKline plc: Research Funding; Sanofi: Consultancy; Daiichi Sankyo: Research Funding; Celgene: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Janssen: Consultancy, Research Funding. Ailawadhi:Janssen: Consultancy, Research Funding; Takeda: Consultancy; Pharmacyclics: Research Funding; Amgen: Consultancy, Research Funding; Celgene: Consultancy; Cellectar: Research Funding. Gasparetto:Celgene: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; Janssen: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed ; BMS: Consultancy, Honoraria, Other: Travel, accommodations, or other expenses paid or reimbursed . Jagannath:AbbVie: Consultancy; Merck &amp; Co.: Consultancy; Bristol-Myers Squibb: Consultancy; Karyopharm Therapeutics: Consultancy; Celgene Corporation: Consultancy; Janssen Pharmaceuticals: Consultancy. Rifkin:Celgene: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees. Durie:Amgen, Celgene, Johnson &amp; Johnson, and Takeda: Consultancy. Narang:Celgene: Speakers Bureau. Terebelo:Celgene: Honoraria; Jannsen: Speakers Bureau; Newland Medical Asociates: Employment. Toomey:Celgene: Consultancy. Hardin:Celgene: Membership on an entity's Board of Directors or advisory committees. Wagner:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees; American Cancer Society: Other: Section editor, Cancer journal. Omel:Celgene, Takeda, Janssen: Other: Patient Advisory Committees. Srinivasan:Celgene: Employment, Equity Ownership. Liu:TechData: Consultancy. Dhalla:Celgene: Employment. Agarwal:Celgene Corporation: Employment, Equity Ownership. Abonour:BMS: Consultancy; Celgene: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Janssen: Consultancy, Research Funding.</jats:p> </jats:sec>
Authors
Lee, HC; Ailawadhi, S; Gasparetto, C; Jagannath, S; Rifkin, RM; Durie, BGM; Narang, M; Terebelo, HR; Toomey, K; Hardin, JW; Wagner, LI; Omel, JL; Srinivasan, S; Liu, L; Dhalla, M; Agarwal, A; Abonour, R
MLA Citation
Lee, Hans C., et al. “Treatment Patterns and Outcomes in Elderly Patients with Newly Diagnosed Multiple Myeloma: Results from the Connect® MM Registry.” Blood, vol. 134, no. Supplement_1, American Society of Hematology, 2019, pp. 3129–3129. Crossref, doi:10.1182/blood-2019-126205.
URI
https://scholars.duke.edu/individual/pub1469907
Source
crossref
Published In
Blood
Volume
134
Published Date
Start Page
3129
End Page
3129
DOI
10.1182/blood-2019-126205

Treatment Patterns From 2009-2015 in Patients With Newly Diagnosed Multiple Myeloma in the United States: A Report From the Connect® MM Registry

Authors
Rifkin, R; Abonour, R; Durie, B; Gasparetto, C; Jagannath, S; Narang, M; Shah, J; Terebelo, H; Toomey, K; Kitali, A; Zafar, F; Srinivasan, S; Hardin, J
MLA Citation
Rifkin, Robert, et al. “Treatment Patterns From 2009-2015 in Patients With Newly Diagnosed Multiple Myeloma in the United States: A Report From the Connect® MM Registry.” Clinical Lymphoma Myeloma and Leukemia, vol. 17, no. 1, Elsevier BV, 2017, pp. e20–21. Crossref, doi:10.1016/j.clml.2017.03.035.
URI
https://scholars.duke.edu/individual/pub1457128
Source
crossref
Published In
Clinical Lymphoma, Myeloma & Leukemia
Volume
17
Published Date
Start Page
e20
End Page
e21
DOI
10.1016/j.clml.2017.03.035

Phase I venetoclax monotherapy for relapsed/refractory multiple myeloma.

Authors
Kumar, S; Vij, R; Kaufman, JL; Mikhael, J; Facon, T; Pegourie, B; Benboubker, L; Gasparetto, C; Amiot, M; Moreau, P; Diehl, S; Alzate, S; Ross, JA; Dunbar, M; Zhu, M; Agarwal, SK; Leverson, J; Maciag, PC; Verdugo, ME; Touzeau, C
MLA Citation
Kumar, Shaji, et al. “Phase I venetoclax monotherapy for relapsed/refractory multiple myeloma.Journal of Clinical Oncology, vol. 34, no. 15, AMER SOC CLINICAL ONCOLOGY, 2016. Wos, doi:10.1200/JCO.2016.34.15_supp1.8032.
URI
https://scholars.duke.edu/individual/pub1292676
Source
wos
Published In
Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology
Volume
34
Published Date
DOI
10.1200/JCO.2016.34.15_supp1.8032

Lenalidomide-Associated ITP.

Lenalidomide is a potent immunomodulatory agent being used increasingly for treatment of hematologic malignancies including multiple myeloma and myelodysplasia. The common toxicities of lenalidomide, including dose-limiting myelosuppression, are well described. However, the immunomodulatory properties of lenalidomide may give rise to unexpected autoimmune complications. Herein, we describe a case of immune thrombocytopenic purpura (ITP) associated with use of lenalidomide.
Authors
Herold, CI; Gasparetto, C; Arepally, GM
MLA Citation
Herold, Christina I., et al. “Lenalidomide-Associated ITP.Case Rep Hematol, vol. 2011, 2011, p. 638020. Pubmed, doi:10.1155/2011/638020.
URI
https://scholars.duke.edu/individual/pub810333
PMID
22937309
Source
pubmed
Published In
Case Rep Hematol
Volume
2011
Published Date
Start Page
638020
DOI
10.1155/2011/638020