NCT00609167 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2011-05-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

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

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outcome · POSTED

Duration of Response

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Number of Participants With Severe Adverse Events

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: 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 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 * 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 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 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

interventions

description
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
name
bortezomib
type
DRUG
description
300mg/m\^2 PO days 1, 8, 15 \& 22
name
cyclophosphamide
type
DRUG
description
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
name
dexamethasone
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 63
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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.
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

secondary Outcomes

description
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
measure
Progression Free Survival (PFS)
time Frame
up to 5 years
description
OS was defined as the time from registration to death of any cause.
measure
Overall Survival (OS)
time Frame
From date of registration until death (up to 5 years)
description
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.
measure
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
time Frame
4 cycles
description
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.
measure
Duration of Response
time Frame
Duration of study (up to 12 cycles)
description
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.
measure
Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 8 Cycles
time Frame
After 8 cycles of treatment
description
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.
measure
Number of Participants Who Responded to Treatment (CR, nCR, VGPR or PR) After 12 Cycles
time Frame
After 12 cycles of treatment
description
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.
measure
Number of Participants With Severe Adverse Events
time Frame
Every cycle during treatment (up to 12 cycles)
description
Evaluation of the ability to successfully collect peripheral blood stem cells following four months (cycles) of combination therapy.
measure
Participants Who Successfully Completed Collection of Peripheral Blood Stem Cells for Transplant
time Frame
After 4 cycles of treatment

Full study description

brief 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. 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.
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.

Source references

references

citation
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.
pmid
19225538
type
RESULT
citation
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.
pmid
20413666
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice