Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Phase I Study of Escalating-Doses of Bendamustine for Patients With Previously Treated Multiple Myeloma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02315157
• Other study ID #: 14D.244
• Secondary ID: 2014-009
• Status: Withdrawn
• Phase: Phase 1

Study information

• Verified date: February 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia, Plasma Cell
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Plasma Cell Leukemia

Intervention

Drug:
• Bendamustine
Given IV

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of bendamustine	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.	2 days
Secondary	Incidence of toxicity (NCI CTCAE version 4.0)	Graded according to NCI CTCAE version 4.0	Up to 92 days following the last administration of study treatment

External Links

•   Jefferson University Hospitals