Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma

NCT02315157 | Withdrawn Phase 1 DMC

• 3 other identifiers: 14D.2442014-009JT 5775
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Plasma Cell Leukemia

Keywords

Partial Response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of toxicity (NCI CTCAE version 4.0)

  Up to 92 days following the last administration of study treatment

Study Arms (2)

Bendamustine 200 mg/m2

EXPERIMENTAL

Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 400 mg/m2).

Drug: Bendamustine

Bendamustine 250 mg/m2

EXPERIMENTAL

Patients receive bendamustine hydrochloride IV over 60-180 minutes on days 1 and 2 (total dose 500 mg/m2).

Drug: Bendamustine

Interventions

Bendamustine DRUG

Given IV

Also known as: Treakisym, Ribomustin, Levact, Treanda, SDX-105

Bendamustine 200 mg/m2; Bendamustine 250 mg/m2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with multiple myeloma who have not achieved a CR following at least 4 cycles of induction therapy
• Age up to 80 years
• ECOG Performance Status of 0 or 1
• Left ventricular ejection fraction =/\> 40%. No uncontrolled arrhythmias or symptomatic cardiac disease
• FEV1, FVC and DLCO =/\> 40%. No symptomatic pulmonary disease.
• 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.
• HIV negative
• Negative beta HCG test in woman with child bearing potential, defined as not post-menopausal for 12 months or no previous sterilization
• Patients or guardian able to sign informed consent
• Availability of previously collected autologous stem cells (at least 3.0 x 106 CD34 cells/kg)
• Calculated GFR \> 50 ml/minute

You may not qualify if:

• Patients with uncontrolled hypertension (systolic \> 140, diastolic \> 90 despite antihypertensive therapy
• Patients with uncontrolled bacteria, viral or fungal infections (currently taking medication and progression of clinical symptoms)
• 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
• Relapsed/refractory myeloma

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Sidney Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center
• Jefferson University Hospitals

MeSH Terms

Conditions

Multiple Myeloma; Leukemia, Plasma Cell

Interventions

Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Leukemia

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Manish Sharma, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 11, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

US (1)