Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma

Phase 1

Withdrawn

• Conditions: Plasma Cell Leukemia; Multiple Myeloma
• Interventions: Drug: Bendamustine

• Registration Number: NCT02315157
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

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.

Study Timeline

• Study First Submitted: 2014-12-09
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-11
• Primary Completion: 2020-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bendamustine 200 mg/m2	Bendamustine	Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 400 mg/m2).
Bendamustine 250 mg/m2	Bendamustine	Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 500 mg/m2).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States