A Phase I/II Dose Escalation Study Assessing the Toxicity and Efficacy of 153-Samarium-EDTMP in Place of TBI in the Conditioning Regimen for PBSCT for Patients With Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 76
- 主要终点
- Proportion of successes (Phase II)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Samarium Sm 153 lexidronam pentasodium contains a radioactive substance that kill cancer cells. Peripheral blood stem cell transplant using stem cells from the patient may be able to replace immune cells that were destroyed by chemotherapy and radioactive drugs used to kill cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of samarium Sm 153 lexidronam pentasodium when given together with high-dose melphalan in treating patients with multiple myeloma undergoing stem cell transplant.
详细描述
OBJECTIVES:
- To find the maximum tolerated dose of samarium Sm 153 lexidronam pentasodium when given with fixed high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplantation in patients with multiple myeloma. (Phase I)
- To assess the response rates of this regimen in these patients. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of samarium Sm 153 lexidronam pentasodium followed by a phase II study.
- Phase I: Patients receive samarium Sm 153 lexidronam pentasodium IV once between days -14 and -10. Patients also receive melphalan IV on day -1. Patients undergo peripheral blood stem cell transplantation on day 0. Patients receive sargramostim (GM-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover.
- Phase II: Patients receive samarium Sm 153 lexidronam pentasodium at the MTD determined in phase I .
Blood samples are collected periodically to determine clearance of samarium Sm 153 lexidronam pentasodium and bone marrow dosimetry.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of multiple myeloma requiring treatment
- •Must have at least 2 x 10^6 CD34+ cells collected for peripheral blood stem cell transplantation
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •ECOG performance status (PS) 0-2 (ECOG PS > 2 allowed if secondary to neuropathy or acute bone event)
- •Direct bilirubin ≤ 2.0 mg/dL
- •Alkaline phosphatase ≤ 750 μ/L
- •Creatinine ≤ 3.0 mg/dL
- •Ejection fraction ≥ 45%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception for 6 months after the completion of study therapy
排除标准
- •DLCO < 50%
- •FVC < 50%
- •FEV_1 < 50%
- •Active malignancy with the exception of nonmelanoma skin cancer
- •Uncontrolled infection
- •NYHA class III-IV cardiac disease
- •PRIOR CONCURRENT THERAPY:
- •May or may not have received prior chemotherapy
- •At least 3 weeks since prior chemotherapy
- •Cyclophosphamide pulsing for stem cell collection allowed
- •At least 4 weeks since prior biologic therapy
- •At least 2 weeks since prior bisphosphonates and bisphosphonates maybe resumed 1 month post-study treatment
结局指标
主要结局
Proportion of successes (Phase II)
Number of toxicity incidents (Phase I)
次要结局
- Number of responses (Phase I)
- Overall survival (Phase II)
- Progression-free survival (Phase II)
- Time to progression (Phase II)
- Progressive disease variables