Clinical trial · Interventional
Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma
Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma: a Pilot Feasibility Study Using a Novel Protocol
- 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 develop a novel platform for allo-SCT in multiple myeloma (MM) with the idea of maximizing anti-myeloma effect with conditioning and minimizing GvHD (graft versus host disease). Specifically, the investigators will use the Flu/Mel (fludarabine and melphalan) regimen. For GvHD prophylaxis, the investigators use the Hopkins PT-Cy (post-transplant cyclophosphamide) platform with the novelty of adding tocilizumab as both an anti-myeloma therapy and as a method to reduce GvHD. IL-6 has an important role in promoting the growth of myeloma cells and progression of disease.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myeloma-Multiple | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Mycophenolate mofetil | Drug | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
| Tocilizumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1 (Flu/Mel/PT-Cy & Tac/MMF for certain cases)
- description
- * Fludarabine 30 mg/m\^2 intravenously (IV) on Days -5, -4, -3, and -2 * Melphalan 140 mg/m\^2 IV on Day -2 * Tocilizumab 8 mg/m\^2 (capped at 800 mg) IV on Day -1 * Stem cell infusion on Day 0 * Cyclophosphamide 50 mg/kg IV on Days +3 and +4 * Tacrolimus 1 mg/day IV on Day +5 (for unrelated \& haploidentical cases) * Mycophenolate mofetil 15 mg/kg orally three times per day on Day +5 (for unrelated \& haploidentical cases) * Filgrastim 10 ug/kg/day subcutaneously until neutrophil recovery starting on Day +5
- interventionNames
- Biological: Tocilizumab
- Drug: Melphalan
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Drug: Tacrolimus
- Drug: Mycophenolate mofetil
- Drug: Filgrastim
Primary outcomes (1)
- measure
- Safety and tolerability of regimen as measured by grade and frequency of adverse events
- timeFrame
- Day +100
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of myeloma. * Between 18 and 70 years of age (inclusive). * Karnofsky performance status ≥ 50% or ECOG performance score of ≤ 2 -Completion of last anti-myeloma therapy (if any) must occur at least 14 days before conditioning. * Must have an HLA-matched sibling, HLA-matched unrelated donor, or a related haploidentical donor: * Available HLA-matched sibling or unrelated donor must meet the following criteria: * At least 18 years of age * HLA donor/recipient match based on at least low-resolution typing per institutional standards (syngeneic donors \[identical twins\] are excluded) * In the investigator's opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting stem cells * No active hepatitis * Negative for HTLV and HIV * Not pregnant OR * Available haploidentical donor must meet the following criteria: * Blood-related family member (sibling (full or half), offspring, parent, cousin, niece or nephew, aunt or uncle, or grandparent) * At least 18 years of age * HLA-haploidentical donor/recipient match by at least low-resolution typing per institutional standards * In the investigator's opinion, is in general good health, and medically able to tolerate leukapheresis required for harvesting stem cells * No active hepatitis * Negative for HTLV and HIV * Not pregnant * Normal bone marrow and organ function as defined below within 14 days prior to first study drug dose (conditioning regimen): * Total bilirubin ≤ 2.5 mg/dl * AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN * Creatinine ≤ 2.0 x ULN OR estimated creatinine clearance ≥ 30 mL/min/1.73 m2 by Cockcroft-Gault Formula (See Appendix C) * Oxygen saturation ≥ 90% on room air * LVEF ≥ 40% * FEV1 and FVC ≥ 40% predicted, DLCOc ≥ 40% predicted * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry through Day +100 visit. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. * Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: * Receiving renal replacement therapy, hemodialysis, or peritoneal dialysis. * Presence of another concurrent malignancy requiring treatment. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan, cyclophosphamide, or other agents used in the study. * Presence of an uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant and/or breastfeeding. * Previous treatment with tocilizumab (TCZ). * Immunization with a live/attenuated vaccine within 28 days prior to conditioning. * Any history of recent serious bacterial, viral, fungal, or other opportunistic infections, precluding a stem cell transplant according to the treating physician. * Serologic evidence of HIV * Active infection with Hepatitis A, B, or C. Active infection is defined as serologic positivity and elevated liver function tests. * History of tuberculosis * Active infection with EBV as defined as EBV viral load ≥ 10,000 copies per mL of whole blood; EBV viral load testing is only required if the patient has clinical signs or symptoms suggestive of active EBV infection * Active infection with CMV as defined as CMV viral load ≥ 10,000 copies per mL of whole blood; CMV viral load testing is only required if the patient has clinical signs or symptoms suggestive of active CMV infection * History of complicated diverticulitis, including fistulae, abscess formation or gastrointestinal (GI) perforation. * Pre-existing CNS demyelination or seizure disorders * Major surgery within preceding 8 weeks * Body weight \>150kg * History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
References
Publications (0)
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