Multiple Myeloma

Newly Diagnosed

Criteria to qualify for this study: Drug used in study:

  • Must have had transplant due to high-risk features  /  Engraftment of neutrophils ANC greater than 1000  / Engraftment of platelets, PLT greater than 60  /  Achievement of at least a PR prior to transplant  /  Absence of GI symptoms  /  Cord blood or haplo transplant not allowed

MM 42 SCRI Millennium

Open-Label Study to Determine the Feasibility of MLN9708 as Maintenance after Allogeneic Stem Cell Transplant for Multiple Myeloma, Followed by an Expansion Phase at the Maximum-Tolerated Dose (MTD)

 

 

 

 

 

 

 

 

Criteria to qualify for this study: Drug used in study:
  • Must have had at least two previous tretment regimens
  • Patients refractory to bortezomib are excluded
  • Patients with active GI issues are excluded.   

    

MM58  SCRI  Janssen

A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexametasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Inelibgible for High Dose Therapy                                          

 

 
 

 

 

 

 

 

 

Criteria to qualify for this study: Drug used in study:
  • Must have at least 10% plasma cells in the marrow M-protein must be present in the serum and/or urine
  • Must have at least 1 myeloma-related organ dysfunction per CRAB criteria
  • Cannot have amyloid
  • PLT must be at least 50 unless marrow contains >50% plasma cells - then PLT must be at least 30
  • ANC must be at least 1000  

    

Dana Farber  DFCI 10-106

A Randomized Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone (RVD) to High-Dose Treatment with Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients up to 65 Years of Age

 

 

 

 

 

 

 

 

 

 


High Risk

 

Criteria to qualify for this study: Drug used in study:
  • Serum monoclonal protein ≥ 3 gm/dL and > 10% plasma cells in the bone marrow with a free light chain ratio outside the range of 0.125 to 8 OR Ratio or abnormal to normal bone marrow plasma cells ≥ 95% or at least one immunoglobulin level lower than the normal range
  • No evidence of CRAB criteria
  • Prior therapy for active Myeloma excluded 

    

Dana Farber  DFCI 14-338 CA-204-119

Phase II Trial of Combination of Elotuxzumab and Lenalidomide ± Dexamethasone in High-Risk Smoldering Multiple Myeloma

 

 

 

 

 

 

 

 

 

 


Relapsed or Refactory 

  

Criteria to qualify for this study: Drug used in study:
  • Must have relapsed or relapsed-and-refratory MM
  • Must have undergone prior treatment with at least 2 cycles of lenalidomideand at least 2 cycles of proteasome inhibitor (same or separate regimens)
  • Must have measurable disease (serum M protein > 0.5g/dL or urine M protein > 200mg/24 hrs).   

    

MM 65   ACE-MM-200

A Phase 1a/1b Multicenter, Single-Arm, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Preliminary Activity of Oral ACY-241 Alone and in Combination with Pomalidomide and Low-dose Dexamethasone in Patients with Relapsed or Relapsed-and-Refractory Multiple Myeloma                                        

 

 

 

 

 

 

 

 

 

Criteria to qualify for this study: Drug used in study:
  • Subjects must have received prior 1 or 2 lines of treatment that should have included at least 2 consecutive cycles of lenalidomide (full therapeutic dose)
  • Lenalidomide regimen to which subject has relapsed or been refractory to is not required to be the most recent regimen received
  • Measurable dz with Serum M protein > 0.5, Urine M proetin > 200, Involved SFLC > 10
  • Excluded if prior pomalidomide or elotuzumab treatment / see protocol for washout periods 

    

MM 66  CA204142 Bristol-Myers Squibb

A Phase 2 Single Arm Study of Elotuzumab in Combination with Pomalidomide and Low-Dose Dexamethasone (Epd) in Patients with Multiple Myeloma Relpased or Refractory to Prior Treatment with Lenalidomide 

COMING SOON                                      

 

 

 

 

 

 

 

 

 

 

Criteria to qualify for this study: Drug used in study:
  • Serum M protein must be at least 1.0 g/dL 
  • Urine M proteint must be at least 200 mg/24hr 
  • Patients requiring anticoagulation with warfarin are excluded 
  • ANC must be at least 1000 
  • PLT must be at least 75 
  • HGB must be at least 8

    

MM 51  SCRI  PCYC-1119-CA

A Multicenter Phase 1/2b Study of the Bruton's Tyrosine Kinase Inhibitor, Ibruitnib (PCI-32765), in Combination with Carfilzomib (Kyprolis) in Subjects with Relapsed or Relapsed and Refractory Multiple Myeloma

ON HOLD                                     

 

 

 

 

 

 

 

 

 

 


Post Transplant