- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02447055
Allogeneic Stem Cell Transplantation for Patients With Multiple Myeloma
July 8, 2016 updated by: Washington University School of Medicine
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.
Study Overview
Status
Withdrawn
Conditions
Study Type
Interventional
Phase
- Early Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm 1 (Flu/Mel/PT-Cy & Tac/MMF for certain cases)
|
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of regimen as measured by grade and frequency of adverse events
Time Frame: Day +100
|
Adverse events will be graded using NCI CTCAE v4.0 and summarized by grade and frequency
|
Day +100
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative incidence and severity of acute GvHD
Time Frame: 6 months
|
6 months
|
|
Cumulative incidence and severity of chronic GvHD
Time Frame: 1 year
|
1 year
|
|
Non-relapse mortality (NRM)
Time Frame: 1 year
|
-NRM is defined as death occurring in a patient from causes other than disease relapse or progression
|
1 year
|
Non-relapse mortality (NRM)
Time Frame: Day +100
|
-NRM is defined as death occurring in a patient from causes other than disease relapse or progression
|
Day +100
|
Progression-free survival (PFS)
Time Frame: 1 year
|
-PFS is defined as the duration from transplant to time of first progression, death, relapse after CR, or the date the patient was last known to be in remission.
|
1 year
|
Overall survival (OS)
Time Frame: 1 year
|
-OS is defined as the duration from the time of transplant to death or last follow-up.
|
1 year
|
Time to neutrophil engraftment
Time Frame: Day +30
|
|
Day +30
|
Time to platelet engraftment
Time Frame: Day +100
|
|
Day +100
|
Non-relapse mortality (NRM)
Time Frame: Day +180
|
-NRM is defined as death occurring in a patient from causes other than disease relapse or progression
|
Day +180
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (ACTUAL)
June 1, 2016
Study Completion (ACTUAL)
June 1, 2016
Study Registration Dates
First Submitted
May 13, 2015
First Submitted That Met QC Criteria
May 15, 2015
First Posted (ESTIMATE)
May 18, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
July 12, 2016
Last Update Submitted That Met QC Criteria
July 8, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Anti-Bacterial Agents
- Adjuvants, Immunologic
- Antibiotics, Antineoplastic
- Antitubercular Agents
- Antibiotics, Antitubercular
- Calcineurin Inhibitors
- Cyclophosphamide
- Lenograstim
- Melphalan
- Fludarabine
- Fludarabine phosphate
- Tacrolimus
- Mycophenolic Acid
Other Study ID Numbers
- 201508102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Myeloma
-
Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
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National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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