Lead Investigator: Ahmad Abuhelwa, University of Sharjah
Title of Proposal Research: Predictors of exposure, therapeutic and adverse effects of medicines used in the treatment of multiple myeloma
Vivli Data Request: 8427
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Multiple myloma (MM) is a cancer of plasma cells and is on the rise worldwide, particularly in the US, Australia, and Western Europe. Nearly 2% of cancer diagnoses and more than 2% of cancer deaths in the US are due to MM. Since 1990, the global incidence of MM has increased by 126% and US incidence by over 40%, whilst global mortality has increased by 94%.
There are many important medicines used in the treatment of multiple myeloma (MM) including ixazomib, daratumumab, and isatuximab. Ixazomib is a proteasome inhibitor which is a drug that inhibit the cellular protein called ‘proteosome’ leading to potein build up and killing of myeloma cells. Daratumumab and isatuximab are monoclonal antibodies are medicines created in the lab and act in a simular fashion to the body’s own antibodies where they help the immune system to recognize and block a specific target. However, response and toxicity to these drugs are highly variable and there are no accurate and reliable tools to date to accurately predict patients who will benefit most. Using the diverse range of data collected from MM clinical trials, including individual’s demographic, clinical, laboratory, disease and genetic characteristics, it is possible to identify predictors and develop clinical tools that enable improved prediction of therapeutic and adverse outcomes from MM medicines. Being able to identify the expected response and adverse effect profile may enable patients and clinicians to make better decisions regarding whether to commence, continue, or change dosing of medicines used in the treatment of MM.
Requested Studies:
A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
Data Contributor: Sanofi
Study ID: NCT02990338
Sponsor ID: EFC14335
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
Data Contributor: Takeda
Study ID: NCT01564537
Sponsor ID: C16010
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation
Data Contributor: Takeda
Study ID: NCT02312258
Sponsor ID: C16021
An Open-Label, Phase 2 Study to Evaluate the Oral Combination of Ixazomib (MLN9708) With Cyclophosphamide and Dexamethasone in Patients With Newly Diagnosed or Relapsed and/or Refractory Multiple Myeloma Requiring Systemic Treatment
Data Contributor: Takeda
Study ID: NCT02046070
Sponsor ID: C16020
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
Data Contributor: Takeda
Study ID: NCT01850524
Sponsor ID: C16014
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma
Data Contributor: Takeda
Study ID: C16010-China
Sponsor ID: C16010-China
Daratumumab (HuMax®-CD38) Safety Study in Multiple Myeloma – Open Label, Dose-escalation Followed by Open Label, Single-arm Study
Data Contributor: Johnson & Johnson
Study ID: NCT00574288
Sponsor ID: CR101876
An Open-label, Multicenter, Phase 2 Trial Investigating the Efficacy and Safety of Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and IMiD) or Are Double Refractory to a Proteasome Inhibitor and an IMiD
Data Contributor: Johnson & Johnson
Study ID: NCT01985126
Sponsor ID: CR102651
Phase 3 Study Comparing Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Subjects With Relapsed or Refractory Multiple Myeloma
Data Contributor: Johnson & Johnson
Study ID: NCT02136134
Sponsor ID: CR103995
Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma
Data Contributor: Johnson & Johnson
Study ID: NCT02076009
Sponsor ID: CR103663
A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy
Data Contributor: Johnson & Johnson
Study ID: NCT02252172
Sponsor ID: CR104762