TriangleNCT04552743 · OUTCOME
Other Measures of Hematopoietic Stem Cell (HSC) Yield in the Apheresis Product
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 2 days
What was measured
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.
Groups in this outcome
MGTA-145 and Plerixafor HSC Mobilization
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. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: 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).
| Group | Source count |
|---|---|
| MGTA-145 and Plerixafor HSC Mobilization | 25 |
Reported measurements
≥ 2.0 x 10e6 CD34+ cells/kg on Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MGTA-145 and Plerixafor HSC Mobilization | 17 | Not reported | Not reported | Not reported | Not reported |
≥ 4.0 x 10e6 CD34+ cells/kg on Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MGTA-145 and Plerixafor HSC Mobilization | 9 | Not reported | Not reported | Not reported | Not reported |
Total ≥ 4.0 x 10e6 CD34+ cells/kg
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MGTA-145 and Plerixafor HSC Mobilization | 17 | Not reported | Not reported | Not reported | Not reported |
Total ≥ 6.0 x 10e6 CD34+ cells/kg
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MGTA-145 and Plerixafor HSC Mobilization | 10 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 17
- title
- ≥ 2.0 x 10e6 CD34+ cells/kg on Day 1
- categories
- measurements
- group Id
- OG000
- value
- 9
- title
- ≥ 4.0 x 10e6 CD34+ cells/kg on Day 1
- categories
- measurements
- group Id
- OG000
- value
- 17
- title
- Total ≥ 4.0 x 10e6 CD34+ cells/kg
- categories
- measurements
- group Id
- OG000
- value
- 10
- title
- Total ≥ 6.0 x 10e6 CD34+ cells/kg
- denoms
- counts
- group Id
- OG000
- value
- 25
- units
- Participants
- description
- 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.
- groups
- description
- 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. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: 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).
- id
- OG000
- title
- MGTA-145 and Plerixafor HSC Mobilization
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 2 days
- title
- Other Measures of Hematopoietic Stem Cell (HSC) Yield in the Apheresis Product
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice