Clinical trial NCT02315157: Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma
Official title: Phase I Study of Escalating-Doses of Bendamustine for Patients With Previously Treated Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Multiple Myeloma
Plasma Cell Leukemia
Keywords: Partial Response
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum tolerated dose of bendamustine
timeFrame: 2 days
Secondary outcomes:
measure: Incidence of toxicity (NCI CTCAE version 4.0)
timeFrame: Up to 92 days following the last administration of study treatment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Manish Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References: