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:
  • —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
  • PLT must be at least 70
  • ANC must be at least 1000

SCRI  MM-27

Phase I/II Study of the Combination of Panobinostat and Carfilzomib in Patients with Relapsed/Refractory Multiple Myeloma

 

 

 

 

 

 

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:

  • Must have measurable disease - Serum M Protein ≥ 0.5 g/dL or Urine Bence-Jones Protein ≥ 200 mg/24hr
  • Cannot have had previous therapy with Pomalidomide
  • Must have documented progression as per the IMWG during or after the last treatment
  • Must have CrCl<30- Only renal impairment arm open

Celgene 008 CBCI-233

A Phase 1 Multi-Center, Open-Label, Dose-Escalation Study to Determine the Pharmacokinetics and Safety of Pomalidomide When Given in Combination With Low Dose Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma and Impaired Renal Function.

 

 

 

 

 

 

 

 

 

 

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
  • —PLT must be at least 50
  • —ANC must be at least 1000
  • Hemoglobin must be at least 8
  • Creatinine clearance of at least 30

SCRI  HEMREF 37

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