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Multiple MyelomaPhase 1/2NCT00920855

Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma

A Phase 1/2 study testing bendamustine and bortezomib in people with Multiple Myeloma, run by Cephalon at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to assess the safety and tolerability of bendamustine as combination therapy with bortezomib for patients with relapsed/refractory multiple myeloma (MM). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
bendamustine and bortezomib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
13 sitesUnited States
Study dates
Jun 2009to Dec 2011
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient:
  • has a diagnosis of multiple myeloma.
  • currently has multiple myeloma with measurable disease.
  • must have received at least 1 previous treatment regimen and shows signs of progressive disease at the time of study entry.
  • if a woman of child bearing potential (not surgically sterile or at least 12 months naturally postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
  • if a man, must agree to use an acceptable method of contraception throughout the study and for 90 days after last dose study drug.
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  • must have an Eastern Cooperative Oncology Group (ECOG) performance status not greater than 2.
  • must have a life-expectancy of greater than 3 months.
  • must meet specific protocol-related hematological and laboratory criteria within 14 days of enrollment.

Who cannot join

  • The patient has:
  • had a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
  • plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes (POEMS) syndrome.
  • plasma cell leukemia.
  • non-measurable multiple myeloma.
  • Common Terminology Criteria for Adverse Events (CTCAE) grade 2 (or greater) peripheral neuropathy within 14 days before enrollment.
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  • previously participated in a Cephalon-sponsored clinical study with bendamustine.
  • impaired cardiac function or clinically significant cardiac diseases.
  • undergone major surgery within 4 weeks prior to screening or has not recovered from side effects of such therapy.
  • severe hypercalcemia.
  • other concurrent severe and/or uncontrolled medical or psychiatric conditions.
  • known positivity for human immunodeficiency virus (HIV) or hepatitis B or C.
  • a history of allergic reaction attributable to compounds of similar chemical or biological composition to bendamustine, bortezomib, boron, or mannitol.
  • received chemotherapy within 3 weeks before enrollment, with the exception of nitrosoureas, which should be discontinued at least 6 weeks before enrollment.
  • received corticosteroids (greater than 10 mg/day prednisone or equivalent) within 3 weeks before enrollment.
  • received immunotherapy, antibody, or radiation therapy within 4 weeks before enrollment.
  • a status as a pregnant or lactating woman. Any women becoming pregnant during the study will be withdrawn from the study.
  • a status as a male whose sexual partner is a woman of childbearing potential not using effective birth control.
  • used an investigational drug within 1 month before the screening visit.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Alivin & Lois Lapidus Cancer Institute

    Baltimore, Maryland

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland

  • Sophia Gordon Cancer Center at Lahey Clinic

    Burlington, Massachusetts

  • Charleston Hematology Oncology, PA

    Charleston, South Carolina

  • Family Cancer Center, PLLC

    Collierville, Tennessee

  • Geisinger Medical Center

    Danville, Pennsylvania

  • Pacific Oncololgy & Hematology

    Encinitas, California

  • Northshore University Health System

    Evanston, Illinois

  • Fairfax Northern Virginia Hematology Oncology

    Fairfax, Virginia

  • Capitol Hematology Oncology

    Roseville, California

  • University Of California, San Diego

    San Diego, California

  • George Washington University

    Washington D.C., District of Columbia

  • James R. Berenson, M.D., Inc.

    West Hollywood, California

Other trials in United States

About this study

Official title: An Open-Label Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma

The primary objective of this study is to assess the safety and tolerability of bendamustine as combination therapy with bortezomib for patients with relapsed/refractory multiple myeloma (MM).

Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bendamustineDrug

    Also called CEP-18083, Bendamustine hydrochloride, TREANDA

    Bendamustine was administered to 3 cohorts of patients at escalating doses of 50 (cohort 1), 70 (cohort 2) and 90 mg/m^2/dose (cohort 3). Doses were administered by intravenous (iv) infusion once daily on days 1 and 4 of each 28-day cycle. Each iv was administered over 60 minutes and followed the injection of bortezomib.

    Bortezomib will be administered to patients at a dose of 1.0 mg/m2/dose as an iv push over 3 to 5 seconds followed by a standard saline flush or through a running iv line. Doses are to be administered to patients on days 1, 4, 8 and 11 of the 28-day cycle.

  • bortezomibDrug

    Also called VELCADE®

    Bortezomib was administered at a dose of 1.0 mg/m^2/dose as an intravenous (iv) push over 3 to 5 seconds followed by a standard saline flush or through a running iv line. Doses are to be administered on days 1, 4, 8 and 11 of each 28-day cycle.

Study groups in NCT00920855
Study groupRoleWhat they receive
Bendamustine and BortezomibExperimentalBendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles.
Receives: Drug: bendamustine; Drug: bortezomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Participants With Dose Limiting Toxicity (DLT)

    Maximum tolerated dose was the dose that was 1 step lower than the dose where at least one third of patients experienced DLT. A DLT was defined as any of the following occurring during the first cycle:

    • grade 4 hematologic toxicity without regard for relationship to study drug treatment
    • thrombocytopenia grade 3 with grade 3 or grade 4 hemorrhage
    • grade 3 febrile neutropenia
    • grade 3 or grade 4 nausea and vomiting refractory to anti emetic therapy
    • any study drug related grade 3 or grade 4 nonhematologic toxicity
    • any drug related death

    Toxicity grades (3=severe AE and 4=life-threatening or disabling AE) were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.

    Measured: Day 1 - 28

Secondary outcomes (8)

  1. Percentage of Participants With An Overall Tumor Response As Assessed By the Investigator

    Overall tumor response is the sum of a complete response (CR), very good partial response (VGPR), partial response (PR) and minimal response (MR). A modified version of the Bladé criteria for response was used. Abbreviated definitions for the response categories can be found in the description of outcome #3.

    Measured: Up to 7.5 months (eight 28-day cycles)

  2. Participants' Best Tumor Response as Assessed by the Investigator

    Abbreviated criteria for response categories: CR includes the disappearance of the original monoclonal protein (M-protein) from blood and urine, and <5% plasma cells in the bone marrow, and no increase in size/number of lytic bone lesions, and disappearance of soft tissue plasmacytomas for >=4 weeks. VGPR includes serum and urine M-protein detectable by immunofixation but not electrophoresis, and reduction in 24-hr urinary light chain excretion by <100 mg, and disappearance of soft tissue plasmacytomas for >= 4 weeks, and no increase in size/number of lytic bone lesions. PR includes a >=50% reduction in serum M-protein, and reduction in 24-hr urinary light chain excretion by either >=90% or to <200 mg, and >=50% reduction in size of soft tissue plasmacytomas, and no increase in size/number of lytic bone lesions. MR includes a >=25% and <=49% reduction in serum M-protein. SD does not meet criteria for the other response categories. See outcome #4 for a definition of PD.

    Measured: up to 7.5 months (eight 28-day cycles)

  3. Kaplan-Meier Estimate for Time to Progression (TTP)

    Time to progression was defined as the time from initiation of therapy to progressive disease (PD). PD requires at least one of the following:

    • >25% increase in serum monoclonal paraprotein (which must also be an absolute increase of at least 5 g/L),
    • >25% increase in 24-hour urinary light chain excretion (which must also be an absolute increase of at least 200 mg/24 h),
    • >25% increase in plasma cells in a bone marrow aspirate or on trephine biopsy (which must also be an absolute increase of at least 10%),
    • definite increase in the size of existing lytic bone lesions or soft tissue plasmacytomas,
    • the development of new bone lesions or soft tissue plasmacytomas,
    • the development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.8 mmol/L not attributable to any other cause).

    Measured: up to 8.6 months

  4. Kaplan-Meier Estimate for Progression-Free Survival

    Progression free survival is the time between the date of initiation of therapy to progressive disease (PD) or death from any cause, whichever occurs first. See outcome #4 for a definition of PD.

    Measured: up to 23 months

  5. Time to the First Response

    Time to first response is defined as the time from the initiation of therapy to the first evidence of a confirmed response (ie, CR, VGPR, PR, or MR).

    Measured: up to 8.5 months

  6. Kaplan-Meier Estimate for Duration of Response

    Duration of response (DR) is defined as the time from the first response to progressive disease (PD). See outcome #4 for a PD definition.

    Measured: up to 8.5 months

  7. Kaplan-Meier Estimate for Overall Survival (OS)

    Overall survival is defined as the time from initiation of therapy to death from any cause or last follow-up visit.

    Measured: up to 23 months

  8. Summary of Participants With Adverse Events (AEs)

    Counts of participants who had AEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0. Severity is rated on a 5-point scale: 1=mild, 2=moderate, 3=severe, 4=life threatening or disabling, and 5= death related to AE. Relatedness is assessed on a 5-point scale: not related, unlikely, possible, probable and definite. Definite, probable and possible answers are reported as 'related' to study medication. Deaths are reported up to 18 months. All the deaths occurred beyond the treatment-emergent timeframe since they occurred 6.5-16 months after the final dosing. All other parts of the summary represent the treatment-emergent timeframe (up to 8.5 months) which is the treatment period plus 30 days.

    Measured: up to 8.5 months. Deaths are reported up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJul 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00920855
Sponsor's protocol ID
C18083/1063/MM/US
Status last verified
Sep 2012
First submitted
11 Jun 2009
Last updated
4 Oct 2012

Publications

  • Berenson JR, Yellin O, Bessudo A, et al. Bendamustine combined with bortezomib has efficacy in patients with relapsed or refractory multiple myeloma: a phase 1/2 study. Blood (ASH Annual Meeting Abstracts). 2011;118 (suppl 21):abstract 1857

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing bendamustine and bortezomib in people with Multiple Myeloma, run by Cephalon at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Dose Limiting Toxicity (DLT) (time frame: Day 1 - 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00920855, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.

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