Clinical trial · Interventional
Stem Cell Transplantation for Patients With Multiple Myeloma
Pilot Study T Cell Depletion in the Setting of Autologous Stem Cell Transplantation for Patients With Multiple Myeloma
NCT01526096CI-TRIAL-00097009completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to test whether regulatory T-cell reduction is possible and safe in myeloma subjects undergoing autologous stem cell transplantation (ASCT).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apheresis | Procedure | — | UNRESOLVED |
| Basiliximab | Drug | — | UNRESOLVED |
| CliniMACS CD25 microbeads and cell sorter | Device | — | UNRESOLVED |
| G-CSF | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Plerixafor | Drug | Plerixafor | ALIAS |
| Stem cell re-infusion | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Standard ASCT (Grp 1)
- description
- Standard autologous stem cell transplantation (ASCT)
- interventionNames
- Drug: G-CSF
- Drug: Plerixafor
- Procedure: Apheresis
- Drug: Melphalan
- Procedure: Stem cell re-infusion
- type
- EXPERIMENTAL
- label
- Depletion of T-cells after ASCT (Grp 2)
- description
- Standard ASCT followed by treatment with basiliximab to remove certain immune cells (called regulatory T-cells or Tregs) from the blood
- interventionNames
- Drug: G-CSF
- Drug: Plerixafor
- Procedure: Apheresis
- Drug: Melphalan
- Procedure: Stem cell re-infusion
- Drug: Basiliximab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Symptomatic multiple myeloma of any subtype in any disease stage, providing that patient does not have smoldering myeloma. * Patient must otherwise be a candidate for ASCT as determined by treating physician. * No current CNS Myeloma at time of enrollment. * Life expectancy greater than 12 weeks. * Age greater than or equal to 21 and less than or equal to 70 years old. * EGOG performance status less than or equal to 2. * No cardiac, pulmonary, hepatic, or renal contraindications for high dose chemotherapy. * HIV Negative. * No active Hepatitis B or C. * Patients must be able to provide written informed, consent. Exclusion Criteria: * Pregnant or nursing women. Women of child-bearing age must be tested for pregnancy. * Use of systemic immunosuppressive medications, including corticosteroids, tacrolimus, mycophenolate mofetil, sirolimus or cyclosporine A. * Psychiatric illness which may make compliance to the clinical protocol unmanageable or which may compromise the ability of the patient to give informed consent. * Active autoimmune disease including but not limited to: rheumatoid arthritis inflammatory bowel disease, celiac disease, systemic lupus erythematosis, scleroderma or multiple sclerosis.
References
Publications (1)
- DERIVEDDerman BA, Zha Y, Zimmerman TM, Malloy R, Jakubowiak A, Bishop MR, Kline J. Regulatory T-cell depletion in the setting of autologous stem cell transplantation for multiple myeloma: pilot study. J Immunother Cancer. 2020 Jan;8(1):e000286. doi: 10.1136/jitc-2019-000286. PMID 31940591