ClinicalTrials.gov
ClinicalTrials.gov Menu

Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple Myeloma (BVRD)

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: NCT01484626
Recruitment Status : Terminated (Celgene would no longer supply lenalidomide for the study)
First Posted : December 2, 2011
Results First Posted : July 10, 2018
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
Scott E Smith, MD, PhD, Loyola University

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Bendamustine Phase 1 Phase 2

Detailed Description:

Multiple myeloma is a multi-organ neoplastic disorder caused by the clonal proliferation of plasma cells. It has an incidence of about 4.5/100,000 per year in the U.S., making it the second most common hematologic malignancy. For many years, alkylating agents have been the backbone of treatment. The combination of melphalan and prednisone was, for many years, the standard of care for patients who were not candidates for autologous transplantation. Melphalan continues to be the primary conditioning agent for autologous transplant,and cyclophosphamide has also gained a foothold in the treatment of this disease.

The introduction of novel agents has fundamentally changed the landscape of treating this disease, although the true effects on survival are not yet known. Immunomodulatory agents and proteosome inhibitors, including thalidomide, lenalidomide and bortezomib have been used in both newly diagnosed and relapsed patients. Currently, there is intense clinical research on the optimal way to combine these novel agents with the traditional backbones of treatment - including alkylators, with one another and, eventually, with the subsequent iterations of these classes of drugs. However, despite the therapeutic excitement surrounding this disease, most patients will relapse and a cure remains an elusive goal.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase I/II Study of Bendamustine, Weekly Bortezomib, Lenalidomide and Dexamethasone for the Treatment of Relapsed or Refractory Multiple Myeloma
Actual Study Start Date : May 5, 2011
Actual Primary Completion Date : June 18, 2014
Actual Study Completion Date : June 18, 2014


Arm Intervention/treatment
Experimental: Bendamustine
Bendamustine is combined with standard chemotherapy.
Drug: Bendamustine
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.
Other Name: Treanda




Primary Outcome Measures :
  1. Number of Patients Experiencing a Toxicity [ Time Frame: 21 days ]
    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.



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.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT01484626


Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Celgene
Investigators
Principal Investigator: Scott Smith, MD, PhD Loyola University

Publications:

Responsible Party: Scott E Smith, MD, PhD, Professor, Loyola University
ClinicalTrials.gov Identifier: NCT01484626     History of Changes
Other Study ID Numbers: 203145
First Posted: December 2, 2011    Key Record Dates
Results First Posted: July 10, 2018
Last Update Posted: July 10, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Scott E Smith, MD, PhD, Loyola University:
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Bendamustine
Bortezomib
Lenalidomide
Dexamethasone
Treanda
Velcade
Revlimid

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, 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
Dexamethasone acetate
Dexamethasone
Lenalidomide
Thalidomide
Bortezomib
Bendamustine Hydrochloride
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists