Immunotherapy for Autologous/Syngeneic Peripheral Blood Stem Cell (PBSC) Transplant Patients as Treatment for Advanced Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Proportion of Patients Alive and in Remission
研究概览
简要总结
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
详细描述
PRIMARY OBJECTIVES:
I. Evaluate initial response to therapy, time to disease progression, and overall survival in MM patients treated with melphalan, IL2- incubated peripheral blood stem cells, and sequential IL2.
SECONDARY OBJECTIVES:
I. Evaluate grade 3-4 toxicities encountered by younger (< 56 years old) and older (>56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment (immunotherapy)
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
干预措施: melphalan (Drug)
Treatment (immunotherapy)
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
干预措施: recombinant interferon alfa (Biological)
Treatment (immunotherapy)
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
干预措施: aldesleukin (Biological)
Treatment (immunotherapy)
Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
干预措施: in vitro-treated peripheral blood stem cell transplantation (Procedure)
结局指标
主要结局
Proportion of Patients Alive and in Remission
时间窗: 12.9 Median Years
Overall Survival
时间窗: 12.9 Median Years
Overall survival in Multiple Myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2 and interferon maintenance.
Initial Response to Therapy
时间窗: Evaluated at Day +84-90 Post-Transplant
Evaluate initial response to therapy (complete remission, partial remission, stable response, or progression of disease)
Time to Disease Progression
时间窗: 12.9 years (median)
次要结局
- Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity(First 100 days post-transplant)
- Number of Patients ≥56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity(First 100 days post-transplant)
研究者
Leona Holmberg
Principal Investigator
Fred Hutchinson Cancer Center