Bortezomib and Bendamustine to Treat Relapsed/Refractory Myeloma

NCT01315873 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 10-02009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with myeloma that has either not responded to previous treatment or has returned after previous treatment will be given a combination of the drugs bendamustine and bortezomib. The bortezomib and bendamustine will be given using an intravenous line (IV) on days 1 and 4 of each cycle, with bortezomib being given first, before each dose of bendamustine. Each cycle will be 28 days long, so patients will be treated the first week of each cycle and then have 3 weeks 'off' (without any treatment). Disease assessments will be performed on day 22 of each cycle. Patients will receive the study drugs until their disease progresses or they are withdrawn from the study. In other studies, bendamustine seems to work well with other drugs. Thus, this study hopes to show that the combination of bortezomib and bendamustine will have activity in relapsed/refractory myeloma.

Conditions

Multiple Myeloma

Keywords

myeloma; multiple myeloma; relapsed myeloma; refractory myeloma

Outcome Measures

Primary Outcomes (1)

• Percent Change Response Rate (Partial Response or Better After 2 Cycles) Following Treatment With Bortezomib and Bendamustine

  These criteria included measures of alteration in the natural history of disease, hematologic improvement, cytogenetic response, and improvement in health-related quality of life.The IWG criteria define 4 aspects of responses based on treatment goals: (1) altering the natural history of the disease, (2) cytogenetic response, (3) hematologic improvement (HI), and (4)Quality of Life (QOL)

  8 weeks

Secondary Outcomes (2)

• Toxicity of This Regimen.

  Every 4 weeks.

• Duration of Response of This Regimen.

  from initial response to relapse, up to 100 weeks.

Study Arms (1)

Bortezomib and Bendamustine

EXPERIMENTAL

Drug: Bendamustine; Drug: Bortezomib

Interventions

Bendamustine DRUG

On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m\^2 after bortezomib . Patients will be dose reduced to 75 mg/m\^2, and then to 60 mg/m\^2 bendamustine on days 1 and 4 if ANC is not \>1 x 10\^9/L and platelets are not \>50 x 10\^9/L on day 1 of each cycle. Patients will be treated until disease progression after at least one cycle of treatment.

Also known as: Bendamustine HCl, Treanda

Bortezomib and Bendamustine

Bortezomib DRUG

On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m\^2 followed by bendamustine given at 90 mg/m\^2. Patients will be dose reduced to 75 mg/m\^2, and then to 60 mg/m\^2 bendamustine on days 1 and 4 if ANC is not \>1 x 10\^9/L and platelets are not \>50 x 10\^9/L on day 1 of each cycle. Patients will be treated until disease progression after at least one cycle of treatment.

Also known as: Velcade

Bortezomib and Bendamustine

Eligibility Criteria

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

You may qualify if:

• Voluntary written informed consent
• Age 18 years or older
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• Male subject agrees to use an acceptable method for contraception for the duration of the study.
• Diagnosis of multiple myeloma based on standard criteria as follows:
• Major Criteria
• Plasmacytomas on tissue biopsy
• Bone marrow plasmacytosis (\>30% plasma cells)
• Monoclonal immunoglobulin spike on serum electrophoresis (IgG \>3.5 g/dL or IgA \>2.0 g/dL) or kappa or lambda light chain excretion \>1 g/day on 24 hour urine protein electrophoresis
• Minor Criteria
• Bone marrow plasmacytosis (10 to 30% plasma cells)
• Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
• Lytic bone lesions
• Normal IgM \<50 mg/dL, IgA \<100 mg/dL, or IgG \<600 mg/dL
• Any of the following sets of criteria will confirm the diagnosis of Multiple Myeloma:

You may not qualify if:

• POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
• Plasma cell leukemia
• Receiving steroids daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
• Infection not controlled by antibiotics
• HIV infection. Patients should provide consent for HIV testing according to the institution's standard practice.
• Known active hepatitis B or C
• New York Hospital Association (NYHA) Class III or IV heart failure, Echo or MUGA ejection fraction \< 40% (if known), or EKG evidence of acute ischemic disease
• Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
• Second malignancy requiring treatment in the last 3 years
• Patient has a calculated or measured creatinine clearance of \<40 mL/min within 14 days before enrollment
• Patient has \>Grade 2 peripheral neuropathy within 14 days before enrollment
• Patient has hypersensitivity to bortezomib, boron or mannitol and bendamustine
• Positive pregnancy test in women of childbearing potential or subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum betaa human chorionic gonadotropin test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
• Patient has received other investigational drugs with 14 days before enrollment
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.

Sponsors & Collaborators

• NYU Langone Health: lead
• Cephalon: collaborator

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Bendamustine Hydrochloride; Bortezomib

Condition Hierarchy (Ancestors)

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; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Michael Grossbard, MD
• Organization: New York University School of Medicine

Michael.Grossbard@nyumc.org

646 501 9305

Study Officials

• Amitabha Mazumder, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2011
• First Posted: March 15, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: September 1, 2015
• Last Updated: February 7, 2018
• Results First Posted: December 8, 2017

Record last verified: 2018-01

Locations

US (1)