A Phase 2 interventional study of MGTA-145 and Plerixafor in Multiple Myeloma, sponsored by Surbhi Sidana, MD. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-10.
Sponsored by Surbhi Sidana, MD · Phase 2, Interventional, and Treatment
This study evaluates a new drug MGTA-145 in combination with plerixafor (Mozobil) to mobilize stem cells into the peripheral blood for collection by apheresis. The stem cells will be used for autologous stem cell transplant for treatment of multiple myeloma.
PRIMARY OBJECTIVE
1. To assess the efficacy of MGTA-145 in combination with plerixafor in mobilizing adequate number of hematopoietic stem cells (> 2 x 10e6 CD34+ cells/kg) in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT).
SECONDARY OBJECTIVES
3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.
This study's enrollment of 25 is below the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →This is the only study on the registry with Surbhi Sidana, MD as lead sponsor.
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Exclusion Criteria:
Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session.
Drug: MGTA-145 · Drug: Plerixafor
A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes.
Also known as: GRO beta
An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
Also known as: Mozobil, AMD 3100, LM-3100
Number of Participants For Whom 2.0 x 10e6 CD34+ HSC Cells/kg Could be Collected in 1 or 2 Apheresis Harvests
The study Primary Objective is to assess the efficacy of hematopoietic stem cells (HSC) mobilization with MGTA-145 in combination with plerixafor in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT). The primary outcome was assessed as the number of participants for whom 2.0 x 10e6 CD34+ HSC cells/kg could be collected in 1 or 2 apheresis harvests, after mobilization with MGTA-145 and Plerixafor. The outcome is reported as the number of participants who achieved this level of HSC cells, a number without dispersion.
Time frame: 2 days
Other Measures of Hematopoietic Stem Cell (HSC) Yield in the Apheresis Product
The study Primary Objective is to assess the efficacy of hematopoietic stem cells (HSC) mobilization with MGTA-145 in combination with plerixafor in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT). Other secondary outcomes were assessed as the number of participants for whom 2.0 or 4.0 x 10e6 CD34+ HSC cells/kg could be collected in the Day 1 apheresis harvest only, and for whom the total yield ≥ 4.0 or ≥ 6.0 x 106 CD34+ cells/kg. The outcome is reported as the number of participants who achieved these levels of HSC cells, a number without dispersion.
Time frame: 2 days
Time To Neutrophil Engraftment
Neutrophil engraftment after hematopoietic stem cells (HSC) transplant (infusion) is an important measure of the medical benefit of the mobilization and hematopoietic stem cells (HSC) infusion procedure. Time to neutrophil engraftment is defined as the number of days from the day of stem cell infusion to the 1st day of 3 consecutive days that absolute neutrophil count (ANC) is ≥ 0.5 x 10e9/L. Only the participants that proceeded to the HSC infusion are included in this outcome, with the outcome is expressed as the median number of days with full range.
Time frame: 15 days
Maintenance of Neutrophil Engraftment [Absolute Neutrophil Count (ANC) ≥ 0.5 x 10e9/L]
Maintenance of successful engraftment after initial engraftment is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants with successful neutrophil engraftment \[absolute neutrophil count (ANC) ≥ 0.5 x 10e9/L\], the outcome is reported as the number of participants that had maintained successful graft status \[absolute neutrophil count (ANC) ≥ 0.5 x 10e9/L\] at 30 days and 100 days after the infusion. The outcome is a number without dispersion.
Time frame: 100 days
Time To Platelet Engraftment ≥ 20 x 10e9/L
Platelet engraftment after hematopoietic stem cells (HSC) transplant (infusion) is an important measure of the medical benefit of the mobilization and hematopoietic stem cells (HSC) infusion procedure. Time to platelet engraftment ≥ 20 x 10e9/L is defined as the 1st day of 2 consecutive days that platelet count is ≥ 20 x 10e9/L, without transfusion in the prior 7 days. Only the participants that proceeded to the HSC infusion are included in this outcome, with the outcome is expressed as the median number of days with full range.
Time frame: 33 days
Time To Platelet Engraftment ≥ 50 x 10e9/L
Platelet engraftment after hematopoietic stem cells (HSC) transplant (infusion) is an important measure of the medical benefit of the mobilization and hematopoietic stem cells (HSC) infusion procedure. Time to platelet engraftment ≥ 50 x 10e9/L s defined as the 1st day that platelet count is ≥ 50 x 10e9/L, without transfusion in the prior 48 hours. Only the participants that proceeded to the HSC infusion are included in this outcome, with the outcome is expressed as the median number of days, with full range.
Time frame: 44 days
Infusion-related Toxicities
Infusion-related toxicities are adverse events considered at least possibly-related to the study treatments MGTA-145, assessed from Baseline to 7 days after mobilization. The outcome is reported as a listing of the preferred terms for the "at least possibly-related" adverse events, with outcome being the number of adverse events of that preferred term. The outcome is a listing of numbers without dispersion.
Time frame: 7 days after mobilization procedure
Progression-free Survival (PFS)
Progression-free survival (PFS) is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants that received the HSC infusion, the outcome is reported as the number of participants who remained alive and were without tumor progression, at 100 days after the infusion. The outcome is a number without dispersion.
Time frame: 100 days after infusion procedure
Transplant-related Mortality
Transplant-related mortality is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants that received the HSC infusion, the outcome is reported as the number of participants who had expired for any reason considered at least possibly related to the transplant / infusion procedure, within 100 days of the infusion. The outcome is a number without dispersion.
Time frame: 100 days after infusion procedure
Non-relapse-related Mortality
For participants that received the HSC infusion, the outcome is reported as the number of participants who had expired for any reason except disease relapse/progression, within 100 days of the infusion. The outcome is a number without dispersion.
Time frame: 100 days after infusion procedure
Overall Survival (OS)
Only patients proceeding with upfront transplant will be assessed. Overall survival is defined as duration from start of the ASCT to death (regardless of cause of death). This will be assessed from start of transplant and OS rates will be reported at day100 following transplant in patients undergoing upfront transplant. Overall survival (OS) is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants that received the HSC infusion, the outcome is reported as the number of participants who remained alive at 100 days after the infusion. The outcome is a number without dispersion.
Time frame: 100 days after infusion procedure
| Milestone | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
The study Primary Objective is to assess the efficacy of hematopoietic stem cells (HSC) mobilization with MGTA-145 in combination with plerixafor in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT). The primary outcome was assessed as the number of participants for whom 2.0 x 10e6 CD34+ HSC cells/kg could be collected in 1 or 2 apheresis harvests, after mobilization with MGTA-145 and Plerixafor. The outcome is reported as the number of participants who achieved this level of HSC cells, a number without dispersion.
| Participants | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| Number of Participants For Whom 2.0 x 10e6 CD34+ HSC Cells/kg Could be Collected in 1 or 2 Apheresis Harvests | 22 |
The study Primary Objective is to assess the efficacy of hematopoietic stem cells (HSC) mobilization with MGTA-145 in combination with plerixafor in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT). Other secondary outcomes were assessed as the number of participants for whom 2.0 or 4.0 x 10e6 CD34+ HSC cells/kg could be collected in the Day 1 apheresis harvest only, and for whom the total yield ≥ 4.0 or ≥ 6.0 x 106 CD34+ cells/kg. The outcome is reported as the number of participants who achieved these levels of HSC cells, a number without dispersion.
| Participants | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| ≥ 2.0 x 10e6 CD34+ cells/kg on Day 1 | 17 |
| ≥ 4.0 x 10e6 CD34+ cells/kg on Day 1 | 9 |
| Total ≥ 4.0 x 10e6 CD34+ cells/kg | 17 |
| Total ≥ 6.0 x 10e6 CD34+ cells/kg | 10 |
Neutrophil engraftment after hematopoietic stem cells (HSC) transplant (infusion) is an important measure of the medical benefit of the mobilization and hematopoietic stem cells (HSC) infusion procedure. Time to neutrophil engraftment is defined as the number of days from the day of stem cell infusion to the 1st day of 3 consecutive days that absolute neutrophil count (ANC) is ≥ 0.5 x 10e9/L. Only the participants that proceeded to the HSC infusion are included in this outcome, with the outcome is expressed as the median number of days with full range.
| days | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| Time To Neutrophil Engraftment | 12 (11 to 15) |
Maintenance of successful engraftment after initial engraftment is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants with successful neutrophil engraftment \[absolute neutrophil count (ANC) ≥ 0.5 x 10e9/L\], the outcome is reported as the number of participants that had maintained successful graft status \[absolute neutrophil count (ANC) ≥ 0.5 x 10e9/L\] at 30 days and 100 days after the infusion. The outcome is a number without dispersion.
| Participants | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| ANC ≥ 0.5 x 10e9/L at 30 days | 19 |
| ANC ≥ 0.5 x 10e9/L at 100 days | 19 |
Platelet engraftment after hematopoietic stem cells (HSC) transplant (infusion) is an important measure of the medical benefit of the mobilization and hematopoietic stem cells (HSC) infusion procedure. Time to platelet engraftment ≥ 20 x 10e9/L is defined as the 1st day of 2 consecutive days that platelet count is ≥ 20 x 10e9/L, without transfusion in the prior 7 days. Only the participants that proceeded to the HSC infusion are included in this outcome, with the outcome is expressed as the median number of days with full range.
| days | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| Time To Platelet Engraftment ≥ 20 x 10e9/L | 18 (15 to 33) |
Platelet engraftment after hematopoietic stem cells (HSC) transplant (infusion) is an important measure of the medical benefit of the mobilization and hematopoietic stem cells (HSC) infusion procedure. Time to platelet engraftment ≥ 50 x 10e9/L s defined as the 1st day that platelet count is ≥ 50 x 10e9/L, without transfusion in the prior 48 hours. Only the participants that proceeded to the HSC infusion are included in this outcome, with the outcome is expressed as the median number of days, with full range.
| days | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| Time To Platelet Engraftment ≥ 50 x 10e9/L | 20 (13 to 34) |
Infusion-related toxicities are adverse events considered at least possibly-related to the study treatments MGTA-145, assessed from Baseline to 7 days after mobilization. The outcome is reported as a listing of the preferred terms for the "at least possibly-related" adverse events, with outcome being the number of adverse events of that preferred term. The outcome is a listing of numbers without dispersion.
| adverse events | Number of Events |
|---|---|
| Pain | 11 |
| Aspartate/alanine aminotransferase increase | 1 |
| Nausea | 2 |
| Headache | 1 |
| Hyperhidrosis | 1 |
| Low platelet count | 2 |
| Vomiting | 1 |
| Poor Graft Function (beyond 7 days post-mobilization) | 1 |
Progression-free survival (PFS) is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants that received the HSC infusion, the outcome is reported as the number of participants who remained alive and were without tumor progression, at 100 days after the infusion. The outcome is a number without dispersion.
| Participants | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| Progression-free Survival (PFS) | 18 |
Transplant-related mortality is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants that received the HSC infusion, the outcome is reported as the number of participants who had expired for any reason considered at least possibly related to the transplant / infusion procedure, within 100 days of the infusion. The outcome is a number without dispersion.
| Participants | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| Transplant-related Mortality | 0 |
For participants that received the HSC infusion, the outcome is reported as the number of participants who had expired for any reason except disease relapse/progression, within 100 days of the infusion. The outcome is a number without dispersion.
| Participants | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| Non-relapse-related Mortality | 0 |
Only patients proceeding with upfront transplant will be assessed. Overall survival is defined as duration from start of the ASCT to death (regardless of cause of death). This will be assessed from start of transplant and OS rates will be reported at day100 following transplant in patients undergoing upfront transplant. Overall survival (OS) is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants that received the HSC infusion, the outcome is reported as the number of participants who remained alive at 100 days after the infusion. The outcome is a number without dispersion.
| Participants | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| Overall Survival (OS) | 19 |
Collected over Per protocol at 7.2.3, adverse events were collected from baseline through 30 days after the last dose of MGTA-145, up to 32 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MGTA-145 and Plerixafor HSC Mobilization | 0/25 (0%) | 0/25 (0%) | 25/25 (100%) |
| Event | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| PainGeneral disorders | 13/25 |
| ParesthesiaNervous system disorders | 7/25 |
| NauseaGastrointestinal disorders | 6/25 |
| Platelet count decreasedInvestigations | 5/25 |
| HypocalcemiaMetabolism and nutrition disorders | 5/25 |
| AnemiaBlood and lymphatic system disorders | 3/25 |
| HypokalemiaMetabolism and nutrition disorders | 3/25 |
| Oral dysesthesiaGastrointestinal disorders | 2/25 |
| VomitingGastrointestinal disorders | 2/25 |
| HeadacheNervous system disorders | 2/25 |
| Age, Categorical(Participants) | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 18 |
| >=65 years | 7 |
| Age, Continuous(years) | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| Median | 62.2 ± 7.8 |
| Sex: Female, Male(Participants) | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| Female | 13 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 20 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 20 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | MGTA-145 and Plerixafor HSC Mobilization |
|---|---|
| United States | 25 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Oct 2020 to primary completion in Jul 2021, 9 months.
Results were first posted in Sep 2022, 1 year 1 month after primary completion.
Of 412 non-industry phase 2 interventional studies under Multiple Myeloma, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 95. This study's 9 months is below that.
Counting every sponsor, half of 502 studies reached it within 55 months; a quarter within 35 and three quarters within 90.
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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: CXCR2 Agonist MGTA-145 · Plerixafor