Clinical Trials
A Phase 1/2 Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN217 in Patients With Relapsed/Refractory Multiple Myeloma
Lead Researcher: Brea C Lipe
An open-label, Phase 1/2 study of HPN217 as monotherapy to assess the safety, tolerability and PK in patients with relapsed/ refractory multiple myeloma
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A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
Lead Researcher: Brea C Lipe
The purpose of this study is to evaluate the efficacy of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).
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A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA, Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects With Relapsed and Lenalidomide-Refractory Multiple Myeloma
Lead Researcher: Brea C Lipe
The purpose of this study is to compare the efficacy of JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).
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A Phase 1b/2a Multicenter, Open-label, Dose-escalation Study to Determine the Maximum Tolerated Dose, Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CC-220 as Monotherapy and in Combination With Other Treatments in Subjects With Multiple Myeloma
Lead Researcher: Brea C Lipe
This is a multicenter, multi-country, open-label, Phase 1b/2a dose-escalation study consisting of two parts: dose escalation (Part 1) for CC-220 monotherapy, CC-220 in combination with DEX, CC-220 in combination with DEX and DARA, CC-220 in combination with DEX and BTZ and CC-220 in combination with DEX and CFZ; and the expansion of the RP2D (Part 2) for CC-220 in combination with DEX for Relapsed Refractory Multiple Myeloma and CC-220 in combination with DEX and BTZ for Newly Diagnosed Multiple Myeloma.
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A Phase 1 Study of SEA-BCMA in Patients With Relapsed or Refractory Multiple Myeloma
Lead Researcher: Brea C Lipe
This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur.
The study will have three parts. In the first part, participants get SEA-BCMA by itself. This part of the study will find out how much SEA-BCMA should be given for treatment and how often. It will also find out how safe the treatment is and how well it works.
In the second part of the study, participants will get SEA-BCMA and dexamethasone. In the third part, participants will get SEA-BCMA, dexamethasone, and pomalidomide. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.
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Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)
Lead Researcher: Brea C Lipe
Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.
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ULAB-16115 A program for following disease progression in Multiple Myeloma
Lead Researcher: Brea C Lipe
The purpose of this study is to collect clinical data along with bone marrow aspirate samples to see if there is a way to determine which patients are more or less likely to experience disease progression. This study will involve identifying different markers on the surfaces of the plasma cells and will look at protein expression. We will then correlate those findings with data from your medical records over time.
If you decide to take part in this study, you will be asked to allow additional bone marrow aspirate and blood samples to be collected for research at several time points. These additional samples will be collected during routine testing time points as required for your routine care. We will also collect information about your disease and treatment from your medical record.
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Publications
Journal Articles
8/4/2021
Keren DF, Bocsi G, Billman BL, Etzell J, Faix JD, Kumar S, Lipe B, McCudden C, Montgomery R, Murray DL, Rai AJ, Redondo TC, Souter L, Ventura CB, Ansari MQ. "Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies: Guideline From the College of American Pathologists in Collaboration With the American Association for Clinical Chemistry and the American Society for Clinical Pathology." Archives of pathology & laboratory medicine.. 2021 Aug 4; Epub 2021 Aug 04.
11/2020
Lipe, B. "Multiple Myeloma Insights: Older Adults With Multiple Myeloma: Q&A on Care Management" . Medpage Today. 2020; .
11/2020
Gasparetto, C; Lentzsch, S; Schiller, G; Callander, N; Tuchman, S; Chen, C; White, D; Kotb, R; Sutherland, H; Sebag, M; Baljevic, M; Bensinger, W; LeBlanc, R; Venner, C; Bahlis, N; Rossi, A; Biran, N; Sheehan, H; Saint-Martin, J; Van Domelen, D; Kai, K; Shah, J; Shacham, S; Kauffman, M; Lipe, B. "Selinexor, daratumumab, and dexamethasone in patients with relapsed or refractory multiple myeloma" . eJHaem. 2020; .
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