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

Phase 2
18 Years
Not Enrolling
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

Trial Information

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



* 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 .


- 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

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.

Inclusion Criteria


- Confirmed diagnosis of symptomatic multiple myeloma

- Durie Salmon stage 2 or higher

- Previously untreated multiple myeloma (including immunomodulatory drugs such as
thalidomide) with the exception of bisphosphonates

- Evaluable or measurable disease, as defined by at least one of the following:

- Serum monoclonal protein ≥ 1 g/dL (measurable disease)

- Urine monoclonal protein ≥ 200 mg/24 hours by protein electrophoresis
(measurable disease)

- Serum-free light chains (FLC) ≥ 10 mg/dL, kappa or lambda, accompanied by an
abnormal kappa/lambda ratio

Serum FLC's should only be used for patients without measurable serum or urine m-spike

- Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)

* Patients diagnosed with smoldering myeloma or monoclonal gammopathy of undetermined
significance are not eligible


Inclusion criteria:

- 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

- 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

- 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

- 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

Exclusion criteria:

- 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

- 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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Description:

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.

Outcome Time Frame:

After 4 months of treatment

Safety Issue:


Principal Investigator

A. Keith Stewart, M.B., Ch.B.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

December 2006

Completion Date:

November 2010

Related Keywords:

  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage II multiple myeloma
  • stage III multiple myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



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