Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | December 2015 |
| End Date: | November 2018 |
| Contact: | John F DiPersio, M.D., Ph.D. |
| Email: | jdipersi@dom.wustl.edu |
| Phone: | 314-454-8304 |
Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma: a Pilot Feasibility Study Using a Novel Protocol
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.
(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.
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.
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