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Multiple Myeloma and Plasma Cell NeoplasmPhase 2NCT00609167

Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

A Phase 2 study testing bortezomib, cyclophosphamide and dexamethasone in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 2 sites in 2 countries.

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

RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bortezomib, cyclophosphamide and dexamethasone
Type of treatment
Injection or infusion
How many people
63 participants
Where
2 sitesin 2 countries
Study dates
Dec 2006to Nov 2010
Phase
Phase 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

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
  • ECOG PS of 3 will be allowed if secondary to pain in the opinion of the Investigator
  • Total bilirubin normal OR direct bilirubin ≤ 2.0 mg/dL
  • Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
  • AST ≤ 3 times ULN
  • Creatinine ≤ 3.5 mg/dL
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  • Absolute neutrophil count ≥ 1,000/mm³ without transfusion or growth factor
  • Platelet count ≥ 100,000/mm³ without transfusion or growth factor
  • Willingness and the physical and mental capability to provide written informed consent
  • Willingness to return to Mayo Clinic Arizona/Princess Margaret Hospital for follow-up
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Who cannot join

  • Peripheral sensory neuropathy ≥ grade 2 as defined by National Cancer Institute (NCI) Common Terminology for Common Adverse Events (CTCAE) version 3.0
  • Known hypersensitivity to compounds containing boron or mannitol
  • Active uncontrolled infection
  • Severe cardiac comorbidity including but not limited to:
  • New York Heart Association class III or IV heart failure
  • History of myocardial infarction within the past 6 months
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  • Uncontrolled angina or electrocardiographic (ECG) evidence of acute ischemia
  • Severe uncontrolled ventricular arrhythmias or ECG evidence of active conduction system abnormalities
  • Cardiac amyloidosis with hypotension (i.e., systolic blood pressure < 100 mm Hg)
  • Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent study compliance or completion of study treatment
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Prior high-dose corticosteroid therapy for 12 days or less is permitted for emergent complications from newly diagnosed multiple myeloma
  • More than 14 days since prior investigational agents
  • No concurrent steroids or any other anticancer agents or treatments
  • Patients may receive the equivalent of up to 20 mg prednisone per day for concurrent illness or adrenal replacement therapy
  • Concurrent palliative radiotherapy for bony pain or fracture is allowed

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259-5499

Other trials in United States

Canada1 site

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2N9

Other trials in Canada

About this study

Official title: A Phase II Trial of Cyclophosphamide, Bortezomib and Dexamethasone (CYBOR-D) in Patients With Newly Diagnosed Active Multiple Myeloma

RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and dexamethasone work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cyclophosphamide and dexamethasone together with bortezomib may kill more cancer cells.

PURPOSE: This phase II trial is studying giving cyclophosphamide and dexamethasone together with bortezomib to see how well it works in treating patients with newly diagnosed multiple myeloma.

Read the detailed description

OBJECTIVES:

Primary

  • To evaluate the response rate (complete response [CR], near CR [nCR], and very good partial response) in patients with newly diagnosed multiple myeloma treated with bortezomib in combination with cyclophosphamide and dexamethasone .

Secondary

  • Determine the overall response rate (partial response, PR, or better) in these patients after 4, 8, and 12 courses of this regimen.
  • Determine the duration of progression-free and overall survival of patients treated with this regimen.
  • To evaluate the toxicity of this regimen in these patients.
  • To evaluate the ability to successfully collect peripheral blood stem cells from these patients after 4 months of this regimen.
  • To evaluate the CR or nCR rate in these patients after 8 and 12 courses of this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral cyclophosphamide on days 1, 8, 15, and 22; bortezomib IV on days 1, 4, 8 , and 11 OR days 1, 8, 15 and 22; and dexamethasone on days 1-4, 9-12, and 17-20 in courses 1 and 2 and days 1, 18, 15, and 22 in all subsequent courses. Courses repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Keywords
stage II multiple myeloma, stage III multiple myeloma
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

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

  • bortezomibDrug

    First 33 patients: 1.3 mg/m^2 IV Days 1, 4, 8 \& 11

    Remaining 30 patients: 1.5 mg/m^2 IV Days 1, 8, 15 \& 22

  • cyclophosphamideDrug

    300mg/m^2 PO days 1, 8, 15 \& 22

  • dexamethasoneDrug

    First 33 patients: 40 mg PO Days 1-4, 9-12, 17-20

    Remaining 30 patients: 40 mg PO Days 1-4, 9-12, 17-20 for cycles 1-2; Days 1, 8, 15, 22 for cycle 3+2 for cycle 3 and beyond

What is being measured

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

  1. Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment

    Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment.

    Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and <5% plasma cells in bone marrow.

    near Complete Response (nCR): Patients who meet all criteria for CR except a positive immunofixation will be classified as nCR.

    Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100mg per 24hours; <=5% plasma cells in bone marrow.

    Measured: After 4 months of treatment

Secondary outcomes (8)

  1. Progression Free Survival (PFS)

    PFS was defined as the time from registration to progression or death due to any cause.

    Progression was defined as any one or more of the following:

    An increase of 25% from lowest confirmed response in:

    • Serum M-component (absolute increase >= 0.5g/dl)
    • Urine M-component (absolute increase >= 200mg/24hour
    • Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)
    • Bone marrow plasma cell percentage (absolute increase of >=10%)
    • Definite development of new bone lesion or soft tissue plasmacytomas

    Measured: up to 5 years

  2. Overall Survival (OS)

    OS was defined as the time from registration to death of any cause.

    Measured: From date of registration until death (up to 5 years)

  3. Number of Participants Who Responded to Treatment (Complete Response,CR; Near Complete Response, nCR; Very Good Partial Response, VGPR; or Partial Response, PR) After 4 Cycles

    Response that was confirmed on 2 consecutive evaluations after 8 months of treatment.

    CR, nCR and VGPR as defined in the primary outcome.

    Partial Response(PR): >=50% reduction in serum M-component and/or

    Urine M-Component >=90% reduction or <200mg per 24hours; or >=50% decrease in difference between involved and uninvolved FLC levels.

    Measured: 4 cycles

  4. Duration of Response

    Duration of response was calculated from the documentation (date) of first response (CR, nCR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded.

    Measured: Duration of study (up to 12 cycles)

  5. Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles

    Response that was confirmed on 2 consecutive evaluations after 8 cycles of treatment.

    Criteria for CR, nCR, VGPR and PR are defined in prior outcomes.

    Measured: After 8 cycles of treatment

  6. Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 12 Cycles

    Response that was confirmed on 2 consecutive evaluations after 12 cycles of treatment.

    Criteria for CR, nCR, VGPR and PR are defined in prior outcomes.

    Measured: After 12 cycles of treatment

  7. Number of Participants With Severe Adverse Events

    Severe adverse events were defined as grade 3 or higher, regardless of attribution to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.

    Measured: Every cycle during treatment (up to 12 cycles)

  8. Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant

    Evaluation of the ability to successfully collect peripheral blood stem cells following four months (cycles) of combination therapy.

    Measured: After 4 cycles of treatment

Timeline

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

  1. First posted6 Feb 2008 (estimated)
  2. Study startDec 2006
  3. Primary completionJan 2009
  4. Study completionNov 2010

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00609167
Sponsor's protocol ID
CDR0000583225
Other IDs
P30CA015083, MC0686, 06-002613, NCI-2010-02147
Status last verified
May 2011
First submitted
31 Jan 2008
Last updated
17 May 2011
Data monitoring committee
Yes

Publications

  • Reeder CB, Reece DE, Kukreti V, Chen C, Trudel S, Hentz J, Noble B, Pirooz NA, Spong JE, Piza JG, Zepeda VH, Mikhael JR, Leis JF, Bergsagel PL, Fonseca R, Stewart AK. Cyclophosphamide, bortezomib and dexamethasone induction for newly diagnosed multiple myeloma: high response rates in a phase II clinical trial. Leukemia. 2009 Jul;23(7):1337-41. doi: 10.1038/leu.2009.26. Epub 2009 Feb 19.

    PubMed 19225538

  • Reeder CB, Reece DE, Kukreti V, Chen C, Trudel S, Laumann K, Hentz J, Pirooz NA, Piza JG, Tiedemann R, Mikhael JR, Bergsagel PL, Leis JF, Fonseca R, Stewart AK. Once- versus twice-weekly bortezomib induction therapy with CyBorD in newly diagnosed multiple myeloma. Blood. 2010 Apr 22;115(16):3416-7. doi: 10.1182/blood-2010-02-271676. No abstract available.

    PubMed 20413666

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib, cyclophosphamide and dexamethasone in people with Multiple Myeloma and Plasma Cell Neoplasm, run by Mayo Clinic at 2 sites in 2 countries.

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 13 inclusion and 17 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 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. 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 phase mean?

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 7 Dec 2010). 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?

Number of Participants Who Achieved a Confirmed Responses Defined as a Complete Response (CR), Near CR or Very Good Partial Response (VGPR) After the First 4 Months of Treatment (time frame: After 4 months of treatment). 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 NCT00609167, which also lists 2 linked publications.

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 17 May 2011.

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