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Research and Clinical Trials

Laboratory and Translational Research in the John C. Davis Program

Translational studies are a fundamental aspect of the modern treatment of plasma cell diseases. A major focus of our research is identifying the genes and proteins that enable malignant plasma cells to survive despite modern treatments and to develop new ways to inhibit those key survival factors. We also provide the opportunity for newly diagnosed patients to have minimal residual disease studies performed once they achieve complete responses with therapy. Minimal residual disease studies will help us further characterize the effectiveness of therapy and the durability of complete responses.

Our research staff handles the bone marrow, blood and stem cells of patients willing to donate to advance our knowledge these diseases. For minimal residual disease testing we employ a state-of-the-art genetic test that is performed on bone marrow cells from diagnosis and at the time of achieving a complete response.

Clinical Trials

These clinical trials are currently open and recruiting patients at Tufts:

For multiple myeloma:

An Open-Label, Multicenter, Phase 1b Study of JNJ-54767414 (HuMax® CD38)(Anti-CD38 Monoclonal Antibody) in Combination with Backbone Regimens for the Treatment of Subjects with Multiple Myeloma

IRB # 11159

Sponsored by Janssen Biotech

https://clinicaltrials.gov/ct2/show/NCT01998971

Alternate study arm available: HuMax® CD38 (Daratumumab) + Carfilzomib-Revlimid-Dexamethasone regimen

Phase 2b Open-Label Single-Arm Selinexor (KPT-330) + Low-Dose Dexamethasone in Patients w/ Multiple Myeloma Quad-refractory to Previous Therapies (STORM)

Sponsored by Karyopharm

https://clinicaltrials.gov/ct2/show/NCT02336815?term=karyopharm&rank=7

E1A11: Randomized Phase III Trial of Bortezomib, Lenalidomide and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite Lenalidomide Maintenance in Patients with Newly Diagnosed Symptomatic Multiple Myeloma

IRB # 105

Sponsored by Eastern Cooperative Oncology Group (ECOG)

https://clinicaltrials.gov/ct2/show/NCT01863550

A Study of Oral Ixazomib Maintenance Therapy in Patients with Newly Diagnosed Multiple Myeloma Not Treated with Stem Cell Transplantation

https://clinicaltrials.gov/ct2/show/NCT02312258 

For systemic AL amyloidosis:

RAIN (Renal AL amyloid Involvement and NEOD001): A Multicenter Randomized Double-blind Phase 2b Study of NEOD001 in Previously Treated Subjects with Systemic Light-chain (AL) Amyloidosis and Persistent Renal Involvement

 IRB # 1196

A Diagnostic Screening Trial Seeking AL Amyloidosis Very Early

IRB# 12016

Sponsored by the Principal Investigator

https://clinicaltrials.gov/ct2/show/NCT02741999

PRONTO: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction

Sponsored by Prothena Therapeutics Ltd.

https://clinicaltrials.gov/ct2/show/NCT02632786

Minimal Residual Disease as a Possible Predictive Factor for Relapse in Patients with AL Amyloidosis

IRB #11829

Sponsored by the Principal Investigator

https://clinicaltrials.gov/ct2/show/NCT02555969?term=NCT02555969&rank

A Phase 3, Randomized, Controlled, Open-Label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physician’s Choice of Treatment Administered to Patients with Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

IRB # 1135836

Sponsored by Millennium Pharmaceuticals

https://clinicaltrials.gov/ct2/show/NCT01659658?term=C16011&rank=1

The Vital Amyloidosis Study, a Phase 3, Multicenter Efficacy and Safety Study of NEOD001

Sponsored by Prothena Therapeutics Ltd.

https://clinicaltrials.gov/ct2/show/NCT02312206?term=prothena&rank=2