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Trial record 2 of 2 for:    AMG 176

AMG 176 First in Human Trial in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02675452
Recruitment Status : Active, not recruiting
First Posted : February 5, 2016
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
At least one dose level of AMG 176 will achieve acceptable safety and tolerability in subjects with relapsed or refractory multiple myeloma and subjects with relapsed or refractory acute myeloid leukemia

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Relapsed or Refractory Acute Myeloid Leukemia Drug: AMG 176 Drug: Dexamethasone Drug: Carfilzomib Drug: Azacitidine Phase 1

Detailed Description:
This is a Phase 1, first-in-human, multicenter; non-randomized, open-label and dose-exploration study of AMG 176 administered IV in subjects with relapsed or refractory multiple myeloma and subjects with relapsed or refractory acute myeloid leukemia The study will be conducted in four parts.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 First in Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 176 in Subjects With Relapsed or Refractory Multiple Myeloma and Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Actual Study Start Date : June 13, 2016
Estimated Primary Completion Date : April 28, 2024
Estimated Study Completion Date : May 30, 2025


Arm Intervention/treatment
Experimental: AMG 176 - Part 1a
Part 1a - dose exploration of the intervention, AMG 176
Drug: AMG 176
Study Drug
Other Name: Study Investigational Product (IP)

AMG 176 - Part 1b
Part 1b dose exploration. The intervention is AMG 176
Drug: AMG 176
Study Drug
Other Name: Study Investigational Product (IP)

AMG 176 - Part 2
Part 2 Combination therapy The intervention is AMG 176
Drug: AMG 176
Study Drug
Other Name: Study Investigational Product (IP)

Drug: Dexamethasone
Non-investigational product

Drug: Carfilzomib
Non-investigational product

Experimental: AMG 176 - Part 3
Part 3 - Dose exploration. The intervention is AMG 176
Drug: AMG 176
Study Drug
Other Name: Study Investigational Product (IP)

Experimental: AMG 176 - Part 4
Part 4 - Dose exploration. The intervention is AMG 176 and azacitidine
Drug: AMG 176
Study Drug
Other Name: Study Investigational Product (IP)

Drug: Azacitidine
Non-investigational product




Primary Outcome Measures :
  1. Multiple Myeloma Part 1a Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the maximum tolerated dose (MTD) for two-consecutive days per week dosing schedule (QD2)

  2. MM Part 1a Incidence of treatment-related adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for QD2

  3. MM Part 1a Incidence of treatment-emergent adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for QD2

  4. MM Part 1a Incidence of clinically significant changes in vital signs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for QD2

  5. MM Part 1a Incidence of clinically significant changes in electrocardiograms (ECGs) [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for QD2

  6. MM Part 1a Incidence of clinically significant changes in clinical laboratory tests [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for QD2

  7. MM Part 1a Pharmacokinetic parameters for AMG 176, including, but not limited to, maximum observed concentration (Cmax) [ Time Frame: 1 month on treatment ]
    Evaluate the pharmacokinetics (PK) of AMG 176 when administered as monotherapy

  8. MM Part 1a Pharmacokinetic parameters for AMG 176, including, but not limited to, area under the concentration-time curve (AUC) [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered as monotherapy

  9. MM Part 1a Pharmacokinetic parameters for AMG 176, including, but not limited to, clearance (CL) [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered as monotherapy

  10. MM Part 1a Pharmacokinetic parameters for AMG 176, including, but not limited to, half-life (t1/2) [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered as monotherapy

  11. MM Part 1b Incidence of DLTs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a once weekly (QW) dosing schedule

  12. MM Part 1b Incidence of treatment-related adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a QW dosing schedule

  13. MM Part 1b Incidence of treatment-emergent adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a QW dosing schedule

  14. MM Part 1b Incidence of clinically significant changes in vital signs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a QW dosing schedule

  15. MM Part 1b Incidence of clinically significant changes in physical examinations [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a QW dosing schedule

  16. MM Part 1b Incidence of clinically significant changes in ECGs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a QW dosing schedule

  17. MM Part 1b Incidence of clinically significant changes in clinical laboratory tests [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory MM and determine the MTD for a QW dosing schedule

  18. MM Part 1b Pharmacokinetic parameters for AMG 176 including, but not limited to Cmax [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered as monotherapy

  19. MM Part 1b Pharmacokinetic parameters for AMG 176 including, but not limited to AUC [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered as monotherapy

  20. MM Part 1b Pharmacokinetic parameters for AMG 176 including, but not limited to CL [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered as monotherapy

  21. MM Part 1b Pharmacokinetic parameters for AMG 176 including, but not limited to t1/2 [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered as monotherapy

  22. MM Part 2 Incidence of DLTs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with carfilzomib and dexamethasone (Kd) in subjects with relapsed or refractory MM and determine the maximum tolerated combination dose (MTC) of AMG 176

  23. MM Part 2 Incidence of treatment-related adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with Kd in subjects with relapsed or refractory MM and determine the MTC of AMG 176

  24. MM Part 2 Incidence of treatment-emergent adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with Kd in subjects with relapsed or refractory MM and determine the MTC of AMG 176

  25. MM Part 2 Incidence of clinically significant changes in vital signs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with Kd in subjects with relapsed or refractory MM and determine the MTC of AMG 176

  26. MM Part 2 Incidence of clinically significant changes in physical examinations [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with Kd in subjects with relapsed or refractory MM and determine the MTC of AMG 176

  27. MM Part 2 Incidence of clinically significant changes in ECGs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with Kd in subjects with relapsed or refractory MM and determine the MTC of AMG 176

  28. MM Part 2 Incidence of clinically significant changes in clinical laboratory tests [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with Kd in subjects with relapsed or refractory MM and determine the MTC of AMG 176

  29. MM Part 2 Pharmacokinetic parameters for AMG 176 and carfilzomib including, but not limited to Cmax [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered in combination with Kd, and PK of carfilzomib when administered in combination with AMG 176

  30. MM Part 2 Pharmacokinetic parameters for AMG 176 and carfilzomib including, but not limited to AUC [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered in combination with Kd, and PK of carfilzomib when administered in combination with AMG 176

  31. MM Part 2 Pharmacokinetic parameters for AMG 176 and carfilzomib including, but not limited to CL [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered in combination with Kd, and PK of carfilzomib when administered in combination with AMG 176

  32. MM Part 2 Pharmacokinetic parameters for AMG 176 and carfilzomib including, but not limited to t1/2 [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered in combination with Kd, and PK of carfilzomib when administered in combination with AMG 176

  33. Acute Myeloid Leukemia (AML) Part 3 Incidence of DLTs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML

  34. AML Part 3 Incidence of treatment-related adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML

  35. AML Part 3 Incidence of treatment-emergent adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML

  36. AML Part 3 Incidence of clinically significant changes in vital signs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML

  37. AML Part 3 Incidence of clinically significant changes in physical examinations [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML

  38. AML Part 3 Incidence of clinically significant changes in ECGs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML

  39. AML Part 3 Incidence of clinically significant changes in clinical laboratory tests [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 monotherapy in subjects with relapsed or refractory AML and determine the MTD for QD2 dosing as a monotherapy in subjects with relapsed or refractory AML

  40. AML Part 3 Pharmacokinetic parameters for AMG 176 including, but not limited to Cmax [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered as monotherapy in subjects with relapsed or refractory AML

  41. AML Part 3 Pharmacokinetic parameters for AMG 176 including, but not limited to AUC [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered as monotherapy in subjects with relapsed or refractory AML

  42. AML Part 3 Pharmacokinetic parameters for AMG 176 including, but not limited to CL [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered as monotherapy in subjects with relapsed or refractory AML

  43. AML Part 3 Pharmacokinetic parameters for AMG 176 including, but not limited to t1/2 [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered as monotherapy in subjects with relapsed or refractory AML

  44. AML Part 4 Incidence of DLTs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the MTC of AMG 176 in combination with azacitidine

  45. AML Part 4 Incidence of treatment-related adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the MTC of AMG 176 in combination with azacitidine

  46. AML Part 4 Incidence of treatment-emergent adverse events [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the MTC of AMG 176 in combination with azacitidine

  47. AML Part 4 Incidence of clinically significant changes in vital signs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the MTC of AMG 176 in combination with azacitidine

  48. AML Part 4 Incidence of clinically significant changes in physical examinations [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the MTC of AMG 176 in combination with azacitidine

  49. AML Part 4 Incidence of clinically significant changes in ECGs [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the MTC of AMG 176 in combination with azacitidine

  50. AML Part 4 Incidence of clinically significant changes in clinical laboratory tests [ Time Frame: Through study completion, an average of 6 months ]
    Evaluate the safety and tolerability of AMG 176 in combination with azacitidine in subjects with relapsed or refractory AML and determine the MTC of AMG 176 in combination with azacitidine

  51. AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine including, but not limited to, Cmax [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered in combination with azacitidine, and PK of azacitidine when administered in combination with AMG 176

  52. AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine including, but not limited to, AUC [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered in combination with azacitidine, and PK of azacitidine when administered in combination with AMG 176

  53. AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine including, but not limited to, CL [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered in combination with azacitidine, and PK of azacitidine when administered in combination with AMG 176

  54. AML Part 4 Pharmacokinetic parameters for AMG 176 and azacitidine including, but not limited to, t1/2 [ Time Frame: 1 month on treatment ]
    Evaluate the PK of AMG 176 when administered in combination with azacitidine, and PK of azacitidine when administered in combination with AMG 176


Secondary Outcome Measures :
  1. MM Part 1a BAX and caspase 3 expression in circulating monocytes and /or circulating monocyte counts [ Time Frame: 6 months on treatment ]
    Demonstrate inactivation of myeloid cell leukemia sequence 1 (MCL1) by the increase of active Bcl 2 associated X protein (BAX) and caspase 3 in circulating monocytes and/or the decrease of circulating monocytes in AMG 176 QD2 treated subjects

  2. MM Part 1a Overall response (OR) according to International Myeloma Working Group uniform response criteria (IMWG-URC) for MM subjects [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 QD2 when given as monotherapy in relapsed or refractory MM

  3. MM Part 1a OR according to IMWG-URC for MM progression-free survival (PFS) [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 QD2 when given as monotherapy in relapsed or refractory MM

  4. MM Part 1a OR according to IMWG-URC for MM time to response [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 QD2 when given as monotherapy in relapsed or refractory MM

  5. MM Part 1a OR according to IMWG-URC for MM duration of response (DOR) [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 QD2 when given as monotherapy in relapsed or refractory MM

  6. MM Part 1b BAX and caspase 3 expression in circulating monocytes and /or circulating monocyte counts [ Time Frame: 6 months on treatment ]
    Demonstrate inactivation of MCL1 by the increase of active BAX and caspase 3 in circulating monocytes and /or the decrease of circulating monocytes in AMG 176 QW treated subjects

  7. MM Part 1b OR according to IMWG-URC for MM subjects [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 QW when given as monotherapy in relapsed or refractory MM

  8. MM Part 1b OR according to IMWG-URC for MM PFS [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 QW when given as monotherapy in relapsed or refractory MM

  9. MM Part 1b OR according to IMWG-URC for MM time to response [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 QW when given as monotherapy in relapsed or refractory MM

  10. MM Part 1b OR according to IMWG-URC for MM DOR [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 QW when given as monotherapy in relapsed or refractory MM

  11. MM Part 2 BAX and caspase 3 expression in circulating monocytes and /or circulating monocyte counts [ Time Frame: 6 months on treatment ]
    Demonstrate inactivation of MCL1 by the increase of active BAX and caspase 3 in circulating monocytes and /or the decrease of circulating monocytes in AMG 176 in combination with Kd treated subjects

  12. MM Part 2 OR according to IMWG-URC for MM subjects [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 when given in combination with Kd in relapsed or refractory MM

  13. MM Part 2 OR according to IMWG-URC for MM PFS [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 when given in combination with Kd in relapsed or refractory MM

  14. MM Part 2 OR according to IMWG-URC for MM time to response [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 when given in combination with Kd in relapsed or refractory MM

  15. MM Part 2 OR according to IMWG-URC for MM DOR [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 when given in combination with Kd in relapsed or refractory MM

  16. AML Part 3 OR according to the 2017 European Leukemia Net (ELN) criteria (Döhner et al, 2017) in AML subjects [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 when given as monotherapy in relapsed or refractory AML

  17. AML Part 3 OR according to the 2017 ELN criteria (Döhner et al, 2017) in AML event free survival (EFS) [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 when given as monotherapy in relapsed or refractory AML

  18. AML Part 3 OR according to the 2017 ELN criteria (Döhner et al, 2017) in AML time to response [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 when given as monotherapy in relapsed or refractory AML

  19. AML Part 3 OR according to the 2017 ELN criteria (Döhner et al, 2017) in AML DOR [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 when given as monotherapy in relapsed or refractory AML

  20. AML Part 4 OR according to the 2017 ELN criteria in AML subjects [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 when given in combination with azacitidine in relapsed or refractory AML

  21. AML Part 4 OR according to the 2017 ELN criteria in AML EFS [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 when given in combination with azacitidine in relapsed or refractory AML

  22. AML Part 4 OR according to the 2017 ELN criteria in AML time to response [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 when given in combination with azacitidine in relapsed or refractory AML

  23. AML Part 4 OR according to the 2017 ELN criteria in AML DOR [ Time Frame: 6 months on treatment ]
    Evaluate preliminary efficacy of AMG 176 when given in combination with azacitidine in relapsed or refractory AML



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • (Multiple myeloma subjects) Pathologically documented, multiple myeloma relapsed or refractory disease after at least 2 lines of therapy
  • (MM subjects only) Measurable disease per the IMWG response criteria
  • (Acute myeloid leukemia subjects) AML as defined by the World Health Organization (WHO) Classification persisting or recurring following one or more treatment courses; EXCEPT acute promyelocytic leukemia.
  • (AML subjects only) More than 5% blasts in bone marrow and Circulating white blood cells (WBCs) < 25,000/ul.
  • Must be willing and able to undergo a core bone marrow biopsy (MM subjects only) and bone marrow aspirate (MM and AML subjects) at screening.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2,
  • (MM subjects only) Satisfactory hematological function without transfusion or growth factor support
  • Life expectancy of > 3 months, in the opinion of the investigator
  • Adequate hepatic function
  • Adequate cardiac function
  • Adequate renal function
  • Female subjects of childbearing potential must have a negative serum or urine pregnancy test
  • Other inclusion criteria may apply

EXCLUSION CRITERIA:

  • Previously received an allogeneic stem cell transplant within 6 months OR having received immunosuppressive therapy within the last three months OR having signs or symptoms of acute or chronic graft-versus-host disease
  • Autologous stem cell transplant less than 90 days prior to study day 1
  • (MM subjects only) Multiple myeloma with IgM subtype
  • (MM subjects only) POEMS syndrome
  • (MM subjects only) Existing plasma cell leukemia
  • (MM subjects only) Waldenstrom's macroglobulinemia
  • (MM subjects only) Amyloidosis
  • (Acute myeloid leukemia Part 4 only) Presence of advanced malignant hepatic tumors with baseline albumin < 3 g/dL
  • Infection requiring intravenous anti-infective treatments within 1 week of study enrollment (day 1)
  • Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II)
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 6 months
  • Enrollment in other investigational procedures while participating in this study
  • Other exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675452


Locations
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United States, California
Research Site
Duarte, California, United States, 91010
Research Site
Sacramento, California, United States, 95817
United States, Illinois
Research Site
Chicago, Illinois, United States, 60637-6613
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02114
United States, New Jersey
Research Site
Hackensack, New Jersey, United States, 07601
United States, Texas
Research Site
Houston, Texas, United States, 77030
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84112
Australia, New South Wales
Research Site
St Leonards, New South Wales, Australia, 2065
Australia, Victoria
Research Site
Melbourne, Victoria, Australia, 3004
Research Site
Parkville, Victoria, Australia, 3050
Canada, Alberta
Research Site
Calgary, Alberta, Canada, T2N 2T9
Canada, Ontario
Research Site
Toronto, Ontario, Canada, M5G 2M9
Germany
Research Site
Aachen, Germany, 52074
Research Site
Ulm, Germany, 89081
Research Site
Würzburg, Germany, 97080
Japan
Research Site
Shinagawa-ku, Tokyo, Japan, 141-8625
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02675452     History of Changes
Other Study ID Numbers: 20150161
2015-004777-32 ( EudraCT Number )
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Azacitidine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents