Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02315157
Recruitment Status : Withdrawn (Withdrawn by PI)
First Posted : December 11, 2014
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Plasma Cell Leukemia Drug: Bendamustine Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Escalating-Doses of Bendamustine for Patients With Previously Treated Multiple Myeloma
Estimated Primary Completion Date : January 2020


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:
  • Treakisym
  • Ribomustin
  • Levact
  • Treanda
  • SDX-105

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:
  • Treakisym
  • Ribomustin
  • Levact
  • Treanda
  • SDX-105




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315157


Locations
Layout table for location information
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
Layout table for investigator information
Principal Investigator: Manish Sharma, MD Thomas Jefferson University

Additional Information:
Layout table for additonal information
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02315157     History of Changes
Other Study ID Numbers: 14D.244
2014-009 ( Other Identifier: CCRRC )
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University ):
Partial Response

Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Bendamustine Hydrochloride
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents