Multiple Myeloma, Plasma Cell Leukemia
Conditions
Keywords
Partial Response
Brief summary
This phase I trial studies the side effects and best dose of bendamustine hydrochloride in treating patients with previously treated multiple myeloma. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Detailed description
PRIMARY OBJECTIVES: I. To identify a maximum tolerated dose of bendamustine (bendamustine hydrochloride) in patients with multiple myeloma. SECONDARY OBJECTIVES: I. To evaluate the safety of escalating doses of bendamustine in patients with multiple myeloma. II. To describe the response after bendamustine OUTLINE: This is a dose-escalation study. Patients receive bendamustine hydrochloride intravenously (IV) over 60-180 minutes on days 1 and 2.
Interventions
DRUGBendamustine
Given IV
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with multiple myeloma who have not achieved a CR following at least 4 cycles of induction therapy 2. Age up to 80 years 3. ECOG Performance Status of 0 or 1 4. Left ventricular ejection fraction =/\> 40%. No uncontrolled arrhythmias or symptomatic cardiac disease 5. FEV1, FVC and DLCO =/\> 40%. No symptomatic pulmonary disease. 6. Serum bilirubin \<2 x upper limit of normal, alkaline phosphatase \<3 x upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites \> 1 L prior to drainage. 7. HIV negative 8. Negative beta HCG test in woman with child bearing potential, defined as not post-menopausal for 12 months or no previous sterilization 9. Patients or guardian able to sign informed consent 10. Availability of previously collected autologous stem cells (at least 3.0 x 106 CD34 cells/kg) 11. Calculated GFR \> 50 ml/minute
Exclusion criteria
1. Patients with uncontrolled hypertension (systolic \> 140, diastolic \> 90 despite antihypertensive therapy 2. Patients with uncontrolled bacteria, viral or fungal infections (currently taking medication and progression of clinical symptoms) 3. New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities 4. Relapsed/refractory myeloma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose of bendamustine | 2 days | Defined as the dose where no more than 1 out of 6 patients experience dose-limiting toxicities. Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of toxicity (NCI CTCAE version 4.0) | Up to 92 days following the last administration of study treatment | Graded according to NCI CTCAE version 4.0 |
Countries
United States
Outcome results
None listed