Refractory Multiple Myeloma Clinical Trial
Official title:
Immunotherapy for Autologous/Syngeneic Peripheral Blood Stem Cell (PBSC) Transplant Patients as Treatment for Advanced Multiple Myeloma
Verified date | June 2016 |
Source | Fred Hutchinson Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
This phase II trial studies the effectiveness of melphalan, peripheral stem cell transplantation, and interleukin-2 followed by interferon alfa in treating patients who have advanced multiple myeloma (MM). Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Interleukin-2 (IL2) may stimulate a person's white blood cells to kill multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells
Status | Completed |
Enrollment | 36 |
Est. completion date | |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 69 Years |
Eligibility |
Inclusion Criteria: - Patient must be less than 70 years old - Patients with advanced Multiple Myeloma that meet the eligibility requirements for mobilization/debulking with Cytoxan/VP-16/G-CSF, Cytoxan/Taxol/G-CSF, or Cytoxan/G-CSF (according to protocol 506.03); if clinically indicated a lower dose of cytoxan than 4g/m2 may be used for mobilization based on the attending's discretion; also, if the patients had previously collected PBSC of sufficient number in the past and meet the other eligibility requirements, they may be entered on this study after approval by the PI - Patients with advanced Multiple Myeloma that have an identical syngeneic twin for donation of PBSCs - Patients have advanced Multiple Myeloma if they were diagnosed initially with stage II or III disease or had stage I disease that progressed after initial therapy or failed to respond to therapy - Syngeneic Donor Inclusion: - Donor and patient have adequate documentation that donor and recipient are syngeneic; including ABO typing, HLA typing and VNTR studies - Donor > 20 kg - Donor meets eligibility to donate according to Standard Practice Guidelines Exclusion Criteria: - Patient's age >= 70 - Karnofsky score less than 80 - A left ventricular ejection fraction less than 50%; Patients with congestive heart disease, history of myocardial infarction (MI), coronary artery disease or any arrhythmia history - Total bilirubin > 1.5 mg/ml (unless history of Gilbert's disease) - Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) > 2 x upper limit of normal - Estimated creatinine clearance < 60 ml/min or creatinine serum > 2.0 mg/dl - Pregnancy - Seropositivity for human immunodeficiency virus - Patients who cannot give informed consent - Secondary malignancies other than basal cell carcinoma of the skin or carcinoma in situ within the last five years - History of seizures or requirement for medicines, such as haldol, for controlling mental disorders - Concurrent need for corticosteroid therapy - Active connective tissue disease - Pleural effusion, pericardial effusion or ascites - Patients allergic to gentamicin - Patients with positive PCR for hepatitis C or hepatitis B - Patients with hypersensitivity to E. coli - derived preparations - Patients with systemic infection at time of IL2 therapy - Patients who previously have had more than 50% of their pelvic area irradiated - Patients with pulmonary function tests that show diffusion capacity (corrected) < 60%, and/or forced expiratory volume in 1 second (FEV1) < 65% of predicted |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | From baseline until disease progression, assessed up to 50 years | No | |
Primary | Initial response to therapy (complete response, partial response, or progression of disease) | 2 years | No | |
Primary | Time to disease progression | From baseline until disease progression, assessed up to 50 years | No | |
Secondary | Number of patients experiencing grade 3-4 regimen related toxicity | From baseline until disease progression, assessed up to 50 years | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04083534 -
First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM)
|
Phase 1/Phase 2 | |
Terminated |
NCT02020941 -
Carfilzomib in Treating Patients With Multiple Myeloma in First Relapse or Refractory to First-Line Therapy
|
Phase 2 | |
Completed |
NCT01775553 -
Study of High Dose Carfilzomib in Multiple Myeloma Patients Who Have Progressed On Standard Dose Carfilzomib
|
Phase 2 | |
Completed |
NCT01212952 -
Pomalidomide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1/Phase 2 | |
Terminated |
NCT01078441 -
Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant
|
Phase 2 | |
Completed |
NCT01233921 -
Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer
|
N/A | |
Completed |
NCT00514137 -
Sunitinib in Treating Patients With Relapsed Multiple Myeloma
|
Phase 2 | |
Completed |
NCT00306813 -
Evaluation of Lenalidomide, Doxorubicin and Dexamethasone (RAD) in Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 1/Phase 2 | |
Completed |
NCT00078858 -
Mycophenolate Mofetil and Cyclosporine in Reducing Graft-Versus-Host Disease in Patients With Hematologic Malignancies or Metastatic Kidney Cancer Undergoing Donor Stem Cell Transplant
|
Phase 1/Phase 2 | |
Completed |
NCT00047203 -
Flavopiridol in Treating Patients With Relapsed or Refractory Multiple Myeloma
|
Phase 2 | |
Active, not recruiting |
NCT03731832 -
Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma
|
Phase 2 | |
Completed |
NCT00003196 -
Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma
|
N/A | |
Recruiting |
NCT03601624 -
Pomalidomide/Cyclophosphamide/Dexamethasone in Relapse Refractory Myeloma: Safety Profile in Mexicans
|
Phase 2 | |
Terminated |
NCT01954784 -
Lenalidomide After Donor Stem Cell Transplant and Bortezomib in Treating Patients With High Risk Multiple Myeloma
|
Phase 1 | |
Recruiting |
NCT05020444 -
TriPRIL CAR T Cells in Multiple Myeloma
|
Phase 1 | |
Completed |
NCT01588015 -
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|
Phase 1 | |
Recruiting |
NCT04302324 -
A Phase II Study of Daratumumab, Clarithromycin, Pomalidomide And Dexamethasone (D-ClaPd) In Multiple Myeloma Patients Previously Exposed to Daratumumab
|
Phase 2 | |
Recruiting |
NCT06119685 -
IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
|
Phase 1/Phase 2 | |
Completed |
NCT00118170 -
Sorafenib in Treating Patients With Metastatic or Unresectable Solid Tumors, Multiple Myeloma, or Non-Hodgkin's Lymphoma With or Without Impaired Liver or Kidney Function
|
Phase 1 | |
Completed |
NCT00054353 -
Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma
|
Phase 1/Phase 2 |