Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma

February 15, 2024 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bendamustine 200 mg/m2
Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 400 mg/m2).
Drug: Bendamustine
Given IV
Other Names:
  • Treanda
  • SDX-105
  • Levact
  • Ribomustin
  • Treakisym
Experimental: Bendamustine 250 mg/m2
Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 500 mg/m2).
Drug: Bendamustine
Given IV
Other Names:
  • Treanda
  • SDX-105
  • Levact
  • Ribomustin
  • Treakisym

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose of bendamustine
Time Frame: 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.
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of toxicity (NCI CTCAE version 4.0)
Time Frame: Up to 92 days following the last administration of study treatment
Graded according to NCI CTCAE version 4.0
Up to 92 days following the last administration of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

  • Principal Investigator: Manish Sharma, MD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Estimated)

January 1, 2020

Study Registration Dates

First Submitted

December 9, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimated)

December 11, 2014

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14D.244
  • 2014-009 (Other Identifier: CCRRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Myeloma

Clinical Trials on Bendamustine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe