Back to resultsINCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma
Primary Purpose
Relapsed or Refractory Multiple Myeloma
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
INCB001158
Daratumumab SC
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma focused on measuring Arginase inhibitor, multiple myeloma, Daratumumab
Eligibility Criteria
Inclusion Criteria:
- Prior diagnosis of multiple myeloma according to IMWG diagnostic criteria.
- Measurable disease at screening.
- Has received at least 3 but not more than 5 prior lines of multiple myeloma treatment, including proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapies.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Willing to avoid pregnancy or fathering children.
- Willing to provide fresh and archival bone marrow aspiration and biopsy tissue.
Exclusion Criteria:
Receipt of any of the following treatment within the indicated interval before the first administration of study drug:
- Anti-myeloma treatment within 2 weeks or 5 half-lives (whichever is longer).
- Investigational drug (including investigational vaccines) or invasive investigational medical device within 4 weeks.
- Autologous stem cell transplant within 12 weeks, or allogeneic stem cell transplant at any time.
- Plasmapheresis within 4 weeks.
- Radiation therapy within 2 weeks.
- Major surgery within 2 weeks, or inadequate recovery from an earlier surgery, or surgery planned during the time the participant is expected to participate in the study or within 2 weeks after the last dose of study treatment.
- Toxicity ≥ Grade 2 from previous anti-myeloma therapy except for stable chronic toxicities (≤ Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.
- Known additional malignancy (other than multiple myeloma) that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
- Laboratory values at screening outside the protocol-defined range.
- Significant concurrent, uncontrolled medical condition including but not limited to known chronic obstructive pulmonary disease (COPD), persistent asthma, or history of asthma within the past 2 years; chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment; acute diffuse infiltrative pulmonary disease; clinically significant or uncontrolled cardiac disease.
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or amyloidosis.
Sites / Locations
- Southern Cancer Center
- Arizona Oncology Associates (Wilmot)
- Rocky Mountain Cancer Centers
- Dana Farber Cancer Institute
- Comprehensive Cancer Centers of Nevada - Twain
- New York Oncology Hematology
- Lineberger Comprehensive Cancer Center At University of North Carolina Chapel Hill
- Oncology Hematology Care, Inc
- Texas Oncology-Austin Midtown
- Texas Oncology - Fort Worth South Henderson
- Texas Oncology San Antonio
- Texas Oncology - Tyler
- University of Virginia
- Virginia Cancer Specialists-Fairfax
- Charite - Universit�Tsmedizin Berlin
- University of Heidelberg
- Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
- Universitatsklinikum Munster
- Hospital General Universitari Vall D Hebron
- Hospital Clinic I Provincial
- Ico Institut Catala D Oncologia
- Hospital Universitario Ramon Y Cajal
- Fundacion Jimenez Diaz University Hospital
- Hospital Universitario 12 de Octubre
- Clinica Universidad de Navarra (Cun)
- Hospital Clinico Universitario de Salamanca
- Hospital Universitario Marques de Valdecilla
- Hospital Universitario Doctor Peset
- Hospital Universitario Y Politcnico de La Fe
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
INCB001158 + daratumumab SC
Daratumumab monotherapy and crossover to INC001158+ daratumumab SC
INCB001158 monotherapy and crossover to INC001158+ daratumumab SC
Arm Description
INCB001158 + daratumumab
Daratumumab will be administered as monotherapy, once confirmed disease progression participants will be crossed over to INCB001158+daratumumad combination therapy.
INCB001158 will be administered as monotherapy, once confirmed disease progression participants will be crossed over to INCB001158+daratumumad combination therapy.
Outcomes
Primary Outcome Measures
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
A TEAE was defined as an adverse event (AE) that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Phase 2: Overall Response Rate (ORR): Number of Participants With a Documented Response of Complete Response (CR), Very Good Partial Response (VGPR), or PR, as Per International Myeloma Working Group (IMWG) Criteria
CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) <100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to <200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.
Secondary Outcome Measures
Phase 1: ORR: Number of Participants With a Documented Response of CR, VGPR, or PR, as Per IMWG Criteria
CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) <100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to <200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.
Phase 2: Number of Participants With Any TEAE
A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Phase 1: Time to Response, Defined as the Time From the First Dose of Study Drug to the First Documented Response of PR or Better (CR, VGPR, or PR), as Per IMWG Criteria
CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) <100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to <200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.
Phase 2: Time to Response, Defined as the Time From the First Dose of Study Drug to the First Documented Response of PR or Better (CR, VGPR, or PR), as Per IMWG Criteria
CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) <100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to <200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.
Phase 1: Duration of Response, Defined as Time From First Documented Response of PR or Better (CR, VGPR, PR), as Per IMWG Criteria, Until Date of Disease Progression or Death, Whichever Occurred First
CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) <100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to <200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.
Phase 2: Duration of Response, Defined as Time From First Documented Response of PR or Better (CR, VGPR, PR), as Per IMWG Criteria, Until Date of Disease Progression or Death, Whichever Occurred First
CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) <100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to <200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.
Progression-free Survival (PFS), Defined as the Duration From the Date of the First Dose of Study Drug Until Either Progressive Disease, as Per IMWG Criteria, or Death, Whichever Occurred First
Progressive disease: increase of 25% from the lowest response value in any one of the following: (a) serum M-component (absolute increase must be ≥0.5 grams per deciliter [g/dL]); (b) urine M-component (absolute increase must be ≥200 mg/24 hours); (c) only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); (d) only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC) percentage (absolute percentage must be ≥10%); (d) bone marrow PC percentage: the absolute percentage must be > 10%; (e) definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; (f) development of hypercalcemia (corrected serum calcium > 11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.
Phase 1: Minimal Residual Disease (MRD), Defined as the Percentage of MRD-negative Participants
Bone marrow aspirate was to be collected for MRD analysis.
Phase 2: MRD, Defined as the Percentage of MRD-negative Participants
Bone marrow aspirate was to be collected for MRD analysis.
Overall Survival
Overall survival was defined as the time from the first dose of study drug to death from any cause until study completion.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03837509
Brief Title
INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma
Official Title
A Randomized Open-Label Phase 1/2 Study of INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Participants With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
This decision follows recruitment difficulties. No safety-related concerns impacted this decision.
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
April 5, 2022 (Actual)
Study Completion Date
April 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and antitumor activity of INCB001158 in combination with daratumumab SC, compared with daratumumab SC alone, in participants with relapsed or refractory multiple myeloma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Multiple Myeloma
Keywords
Arginase inhibitor, multiple myeloma, Daratumumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
An initial equal randomization of participants between INCB001158 in combination with daratumumab SC (Treatment Group A), daratumumab SC monotherapy (Treatment Group B), and INCB001158 monotherapy (Treatment Group C) will be conducted. Participants in the treatment groups B and C at confirmed disease progression will be crossed over to INCB001158 + daratumumab SC. After the equal randomization period, a response adaptive randomization design will be used to compare the objective response rate of Treatment Groups A and B with adjustments to the randomization rate based on the observed objective response rate.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INCB001158 + daratumumab SC
Arm Type
Experimental
Arm Description
INCB001158 + daratumumab
Arm Title
Daratumumab monotherapy and crossover to INC001158+ daratumumab SC
Arm Type
Active Comparator
Arm Description
Daratumumab will be administered as monotherapy, once confirmed disease progression participants will be crossed over to INCB001158+daratumumad combination therapy.
Arm Title
INCB001158 monotherapy and crossover to INC001158+ daratumumab SC
Arm Type
Experimental
Arm Description
INCB001158 will be administered as monotherapy, once confirmed disease progression participants will be crossed over to INCB001158+daratumumad combination therapy.
Intervention Type
Drug
Intervention Name(s)
INCB001158
Intervention Description
Phase 1: INCB001158 administered orally twice daily at the protocol-defined starting dose, with dose escalation/de-escalation based on protocol-defined toxicity criteria to determine the maximum tolerated dose. INCB001158 is administered in combination with daratumumab SC. Phase 2: INCB001158 administered orally at the recommended dose from Phase 1 either as a monotherapy or in combination with daratumumab SC.
Intervention Type
Biological
Intervention Name(s)
Daratumumab SC
Intervention Description
Daratumumab 1800 mg co-formulated with rHuPH20 (2000 U/mL) and administered subcutaneously once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and then once every 4 weeks. Daratumumab will be administered either as monotherapy or in combination with INCB001158.
Primary Outcome Measure Information:
Title
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Description
A TEAE was defined as an adverse event (AE) that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Time Frame
up to 454 days
Title
Phase 2: Overall Response Rate (ORR): Number of Participants With a Documented Response of Complete Response (CR), Very Good Partial Response (VGPR), or PR, as Per International Myeloma Working Group (IMWG) Criteria
Description
CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) <100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to <200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.
Time Frame
up to Day 386
Secondary Outcome Measure Information:
Title
Phase 1: ORR: Number of Participants With a Documented Response of CR, VGPR, or PR, as Per IMWG Criteria
Description
CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) <100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to <200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.
Time Frame
up to Day 395
Title
Phase 2: Number of Participants With Any TEAE
Description
A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Time Frame
up to 420 days
Title
Phase 1: Time to Response, Defined as the Time From the First Dose of Study Drug to the First Documented Response of PR or Better (CR, VGPR, or PR), as Per IMWG Criteria
Description
CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) <100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to <200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.
Time Frame
up to Day 395
Title
Phase 2: Time to Response, Defined as the Time From the First Dose of Study Drug to the First Documented Response of PR or Better (CR, VGPR, or PR), as Per IMWG Criteria
Description
CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) <100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to <200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.
Time Frame
up to Day 386
Title
Phase 1: Duration of Response, Defined as Time From First Documented Response of PR or Better (CR, VGPR, PR), as Per IMWG Criteria, Until Date of Disease Progression or Death, Whichever Occurred First
Description
CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) <100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to <200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.
Time Frame
up to Day 395
Title
Phase 2: Duration of Response, Defined as Time From First Documented Response of PR or Better (CR, VGPR, PR), as Per IMWG Criteria, Until Date of Disease Progression or Death, Whichever Occurred First
Description
CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) <100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to <200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.
Time Frame
up to Day 386
Title
Progression-free Survival (PFS), Defined as the Duration From the Date of the First Dose of Study Drug Until Either Progressive Disease, as Per IMWG Criteria, or Death, Whichever Occurred First
Description
Progressive disease: increase of 25% from the lowest response value in any one of the following: (a) serum M-component (absolute increase must be ≥0.5 grams per deciliter [g/dL]); (b) urine M-component (absolute increase must be ≥200 mg/24 hours); (c) only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be > 10 mg/dL); (d) only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC) percentage (absolute percentage must be ≥10%); (d) bone marrow PC percentage: the absolute percentage must be > 10%; (e) definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; (f) development of hypercalcemia (corrected serum calcium > 11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.
Time Frame
up to approximately 2 years
Title
Phase 1: Minimal Residual Disease (MRD), Defined as the Percentage of MRD-negative Participants
Description
Bone marrow aspirate was to be collected for MRD analysis.
Time Frame
up to approximately 2 years
Title
Phase 2: MRD, Defined as the Percentage of MRD-negative Participants
Description
Bone marrow aspirate was to be collected for MRD analysis.
Time Frame
up to approximately 2 years
Title
Overall Survival
Description
Overall survival was defined as the time from the first dose of study drug to death from any cause until study completion.
Time Frame
up to 923 days (approximately 2.5 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prior diagnosis of multiple myeloma according to IMWG diagnostic criteria.
Measurable disease at screening.
Has received at least 3 but not more than 5 prior lines of multiple myeloma treatment, including proteasome inhibitor, immunomodulatory drug, and anti-CD38 therapies.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Willing to avoid pregnancy or fathering children.
Willing to provide fresh and archival bone marrow aspiration and biopsy tissue.
Exclusion Criteria:
Receipt of any of the following treatment within the indicated interval before the first administration of study drug:
Anti-myeloma treatment within 2 weeks or 5 half-lives (whichever is longer).
Investigational drug (including investigational vaccines) or invasive investigational medical device within 4 weeks.
Autologous stem cell transplant within 12 weeks, or allogeneic stem cell transplant at any time.
Plasmapheresis within 4 weeks.
Radiation therapy within 2 weeks.
Major surgery within 2 weeks, or inadequate recovery from an earlier surgery, or surgery planned during the time the participant is expected to participate in the study or within 2 weeks after the last dose of study treatment.
Toxicity ≥ Grade 2 from previous anti-myeloma therapy except for stable chronic toxicities (≤ Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy.
Known additional malignancy (other than multiple myeloma) that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry.
Laboratory values at screening outside the protocol-defined range.
Significant concurrent, uncontrolled medical condition including but not limited to known chronic obstructive pulmonary disease (COPD), persistent asthma, or history of asthma within the past 2 years; chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment; acute diffuse infiltrative pulmonary disease; clinically significant or uncontrolled cardiac disease.
Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or amyloidosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Gogov, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Southern Cancer Center
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Facility Name
Arizona Oncology Associates (Wilmot)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada - Twain
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
New York Oncology Hematology
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center At University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Oncology Hematology Care, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Texas Oncology-Austin Midtown
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Oncology - Fort Worth South Henderson
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia Cancer Specialists-Fairfax
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Charite - Universit�Tsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69117
Country
Germany
Facility Name
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitatsklinikum Munster
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Hospital General Universitari Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Ico Institut Catala D Oncologia
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Fundacion Jimenez Diaz University Hospital
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Clinica Universidad de Navarra (Cun)
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Doctor Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Hospital Universitario Y Politcnico de La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma
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