Multiple Myeloma

Newly Diagnosed

Criteria to qualify for this study: Drug used in study:
  • Must have measurable disease - Serum M Protein ≥ 0.5 g/dL
  • Urine M-Protein ≥ 200 mg/24hr
  • Involved FLC level  ≥ 10 mg/dl & FLC ratio is abnormal
  • ANC  ≥ 1000, PLT  ≥ 75, HGB  ≥ 7

SCRI MM-43 - Onyx

Phase 1b/2, Multicenter, Open-Label Study of Oprozomib, Lenalidomide, and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma. OPZ003

 

 

 

 

 

 
 


Relapsed or Refactory

Criteria to qualify for this study: Drug used in study:
  • —Serum M-protein lof at least 1.0 and/or urine M-protein  of at least 200 mg/24hr.
  • Carfilzomib naïve
  • Patients treated with Carfilzomib must have achieved at least a PR and had PD at least 60 days after treatment
  • Carfilzomib refractory must have been treated with  at least 20/27 mg/m2
  • PLT at least 30, ANC at least 1000, HGB at least 7

Dana Farber - Onyx 2011-001

Phase 1b/2, Multicenter, Open-Label Study of the Safety and Activity of Oprozomib in Patients with Hematologic Malignancies

 

 

 

 

 

 

 

 

Criteria to qualify for this study: Drug used in study:
  • —Patient must have received 2 prior therapies which must have included boretzomib and lenalidomide or thalidomede (alone or in combination) / No prior history of carfilzomib exposure unless subject has had at leaxt a PR to carfilzomib therapy

MM 47 SCRI Onyx

A Phase I b/3 Multicenter Study of Oprozomib, Pomalidomide, and Dexamethasone in Primary Refractory or Relapsed and Refractory Multiple Myeloma Subjects -                                                COMING SOON

 

 

 

 

 

 

Criteria to qualify for this study: Drug used in study:
  • Serum M-protein level of at least 0.5 and/or urine M- protein  level of at least 200 mg/24hr.
  • Patient must have received 2 prior therapies which must have included bortezomib and an immunomodulatory agent
  • PLT must be at least 75, ANC must be at least 1000 

SCRI  MM-52 MMRC

A Phase I Study of Ganetespib ± Bortezomib in Patients with Relapsed and/or Refractory Multiple Myeloma

 

 

 

 

 

 

 

Criteria to qualify for this study: Drug used in study:
  • Serum M-protein level of at least 1.0 and/or urine M-protein  level of at least 200 mg/24hr.
  • Patient must have received at least 2 prior therapies which must  2 cycles must have included bortezomib and 2 cycles must have included lenalidomide
  • Disease must be refractory to a carfilzomib and/or a pomalidomide-containg regimen.

SCRI  MM-53 ARRAY-520-215

A Multicenter Phase 2 Study of Single-Agent Filanesib (ARRY-520) in Patients With Advanced Multiple Myeloma

 

 

 

 

 

 

 

 

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

  • Patients must have no available approved therapies that confer clinical benefit  /  Peripheral blood blasé count must be 30 or less  / No APL  / DLCO less than 50% of predicted not allowed  /  No CNS disease

SCRI  HEMREF 37 CX-839-002

A Phase 1 Study  of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminiase Inhibitor CB-839 in Patients with Advanced and/or Treatment-Refractory Hematological Malignancies

 

 

 

 

 

 

 

Criteria to qualify for this study: Drug used in study:
  • Serum M-protein level of at least 1.0 and/or urine M-protein level of at least 200 mg/24hr.
  • Patients requiring anticoagulation with warfarin are excluded
  • PLT must be at least 75
  • ANC must be at least 750
  • —Hemoglobin must be at least 8

SCRI  MM-51

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

 

 

 

 

 

 

 


Post Transplant

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)