Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple Myeloma

NCT01484626 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 203145
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine the safety and efficacy of the use of bendamustine in combination with a commonly used combination chemotherapy to treat relapsed and refractory multiple myeloma. The study will be conducted in two phases. Participants in phase I will receive 1 of 4 escalating doses of bendamustine. Once the maximum tolerated dose of bendamustine is determined, phase II of this trial will begin. Participants in phase II will receive the maximum tolerated dose of bendamustine in combination with standard of care chemotherapy.

Conditions

Multiple Myeloma

Keywords

Relapsed Multiple Myeloma; Refractory Multiple Myeloma; Bendamustine; Bortezomib; Lenalidomide; Dexamethasone; Treanda; Velcade; Revlimid

Outcome Measures

Primary Outcomes (1)

• Number of Patients Experiencing a Toxicity

  The number of patients experiencing at least one toxicity at the lowest dose of bendamustine. A toxicity is defined as one or more of the following: Upper respiratory infection; anemia; thrombocytopenia; neutropenia; shortness of breath on exertion; decreased appetite; nausea; neuropathy; anxiety; arthritis; and hypercalcemia.

  21 days

Study Arms (1)

Bendamustine

EXPERIMENTAL

Bendamustine is combined with standard chemotherapy.

Drug: Bendamustine

Interventions

Bendamustine DRUG

The first group of three patients to enter the study will receive a 25 mg/m\^2 dose of bendamustine. If this dose is found to be safe, the next three patients will receive 50 mg/m\^2. Using a modified Fibonacci dose-escalation design, the dose will continue to increase at a rate of 25 mg/m\^2 until the highest safe dose of bendamustine is found. The maximum dose will be 125 mg/m\^2. Bendamustine and bortezomib will be given through a catheter twice a week every 21 days. Dexamethasone and lenalidomide will be given orally. In general, a cycle of chemotherapy will last 21 days.

Also known as: Treanda

Bendamustine

Eligibility Criteria

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

You may qualify if:

• Adults with relapsed and/or refractory myeloma who have received between 1-4 prior lines of therapy
• Must have adequate liver and renal function
• Zubrod Performance Status (ZPS) of 2 or better
• Must have measurable disease

You may not qualify if:

• Peripheral neuropathy of grade II or higher
• Thrombocytopenia (platelets less than 50,000/uL)
• Neutropenia (ANC\<1000/uL)
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.4 X ULN
• Total bilirubin \>1.5 X upper limit of normal (ULN)
• Creatinine clearance of less than 45 milliliters per minute (mL/min)
• Patients with HIV
• Patients with active hepatitis
• Pregnant or lactating women
• Individuals of child-bearing potential not using adequate contraception
• Individuals unable to provide informed consent

Sponsors & Collaborators

• Loyola University: lead
• Celgene: collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (43)

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MeSH Terms

Conditions

Multiple Myeloma

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

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

Limitations and Caveats

The trial terminated in June 2014 when Celgene could no longer supply lenalidomide for the study

Results Point of Contact

• Title: Scott Smith, M.D., Ph.D.
• Organization: Loyola University Medical Center

ssmith8@lumc.edu

708-327-3142

Study Officials

• Scott Smith, MD, PhD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: December 2, 2011
• Study Start: May 5, 2011
• Primary Completion: June 18, 2014
• Study Completion: June 18, 2014
• Last Updated: July 10, 2018
• Results First Posted: July 10, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)