NCT02002598 · REGISTRY CONDITION SEARCH

Carfilzomib With Bendamustine and Dexamethasone in 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: PHASE1, PHASE2
Status at capture: TERMINATED
Registry last update: 2024-09-19

This study is designed to define dose-limiting toxicity and determine preliminary evidence of efficacy of carfilzomib (CFZ) in combination with bendamustine and dexamethasone for patients with newly diagnosed multiple myeloma (MM).

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

→

baseline

Baseline characteristics

→

outcome · POSTED

Maximum Tolerated Dose (MTD) of Carfilzomib in Combination With Bendamustine and Dexamethasone

→

outcome · POSTED

Overall Response Rate (ORR)

→

outcome · POSTED

Time to Next Treatment (TTNT)

→

outcome · POSTED

Progression Free Survival (PFS)

→

outcome · POSTED

Time to Best Response

→

outcome · POSTED

Overall Survival (OS) Rate

→

outcome · POSTED

Number of Adverse Events (AEs)

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: 1. Age ≥ 18 years. 2. Life expectancy ≥ 3 months. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 4. Adequate hepatic function. 5. Sufficient Absolute neutrophil count (ANC) within 14 days prior to randomization. 6. Sufficient Hemoglobin within 14 days prior to randomization (subjects may be receiving red blood cell (RBC) transfusions in accordance with institutional guidelines). 7. Sufficient platelet count 14 days prior to randomization. 8. Creatinine Clearance ≥ 30 mL/minute within 7 days prior to randomization. 9. Left Ventricular Ejection Fraction ≥ 40%. 10. Written informed consent in accordance with federal, local, and institutional guidelines. 11. Females of childbearing potential (FCBP) must agree to ongoing pregnancy testing and to practice contraception. 12. Male subjects must agree to practice contraception. 13. Patients must have histologically or cytologically confirmed symptomatic multiple myeloma (MM). Patients should not have previously been treated. 14. Prior kyphoplasty, vertebroplasty, local radiation therapy for symptomatic bone lesions (e.g., uncontrolled pain or high risk of pathologic fracture) are permitted. 15. Patients are allowed up to two cycles of high dose steroids if needed for symptomatic disease before study enrollment. Exclusion Criteria: 1. Patients who have had chemotherapy for Multiple Myeloma. Exception: local radiation therapy for symptomatic bone lesions (e.g., uncontrolled pain or high risk of pathologic fracture). 2. Patients currently receiving high dose systemic steroids for treatment of Multiple Myeloma in excess of 320mg total dose of dexamethasone or equivalent, patients who received an investigational agent within 5 half-lives of the agent. 3. Patients with non-measurable Multiple Myeloma or primary plasma cell leukemia. 4. Pregnant or lactating females. 5. Major surgery within 21 days prior to enrollment. 6. Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment. 7. Known human immunodeficiency virus (HIV) infection. 8. Known active hepatitis B or C infection. 9. Unstable angina or myocardial infarction within 4 months prior to enrollment. 10. Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment. 11. Uncontrolled, non-hematologic malignancy requiring active treatment. 12. Patients with known brain metastases (treated or not) will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 13. Significant neuropathy within 14 days prior to randomization. 14. Known history of allergy to Captisol, or to other agents in the study. 15. Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment. 16. Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrollment. 17. Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Subjects will receive Carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days with dose escalation from 27, 36, 45 to 56 mg/ m2 . No matter what target dose the subject will receive, days 1 and 2 doses in the first cycle will always be 20 mg/m2, followed by target dose for all subsequent dates and cycles. Bendamustine will be given IV on days 1 and 2 with dose escalation up to 90 mg/m2 and dexamethasone 20 mg orally or intravenously on 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day cycle. Study treatment will be given until 8 cycles of treatment are completed or until disease progression, whichever comes first.
intervention Names
Drug: Bendamustine
Drug: Carfilzomib
Drug: Dexamethasone
label
CFZ with bendamustine and dexamethasone
type
EXPERIMENTAL

interventions

arm Group Labels
CFZ with bendamustine and dexamethasone
description
Bendamustine will be administered IV on days 1 and 2 with dose escalation up to 90 mg/m2 of each 28-day cycle. Dose escalation is as follows: -1 \| 60 mg/m2 1. \| 70 mg/m2 2. \| 70 mg/m2 3. \| 90 mg/m2 4. \| 90mg/m2 5. \| 90 mg/m2
name
Bendamustine
other Names
Treanda
type
DRUG
arm Group Labels
CFZ with bendamustine and dexamethasone
description
Carfilzomib will be administered IV on Days 1, 2, 8, 9, 15, and 16 every 28 days. Dose Escalation is as follows: -1 \| 27 mg/m2 1. \| 27 mg/m2 2. \| 36 mg/m2 3. \| 36 mg/m2 4. \| 45 mg/m2 5. \| 56 mg/m2
name
Carfilzomib
other Names
Kyprolis
CFZ
type
DRUG
arm Group Labels
CFZ with bendamustine and dexamethasone
description
Dexamethasone will be administered PO or IV, 20 mg, on 1, 2, 8, 9, 15, 16 and 22, 23 of each 28-day cycle.
name
Dexamethasone
other Names
Decadron
Dexamethasone Intensol
Dexpak Taperpak
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 23
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
MTD defined as the highest dose at which ≤20% of participants experience dose-limiting toxicity (DLT), to define the recommended phase II dose. DLT were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute version 4.0. An AE was considered a DLT if it occurred in cycle 1, was deemed related to study treatment, and was one of peripheral neuropathy ≥grade 2, any non-hematologic AE ≥ grade 3, neutropenia grade 4 lasting ≥7 days or with fever, thrombocytopenia grade 4 lasting ≥7 days or with bleeding, or any AE requiring a dose reduction during cycle 1 or a delay in the start of cycle 2.
measure
Maximum Tolerated Dose (MTD) of Carfilzomib in Combination With Bendamustine and Dexamethasone
time Frame
6 months

secondary Outcomes

description
ORR defined as the number of participants demonstrating complete response or partial response. Complete response defined as complete disappearance of an M-protein and no evidence of MM in the bone marrow. Partial response defined as ≥50% reduction in the level of the serum monoclonal paraprotein, reduction in 24-hour M-protein either by greater than or equal to 90% or to \<200 mg, ≥50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination), no increase in the number or size of lytic bone lesions.
measure
Overall Response Rate (ORR)
time Frame
2 years
description
The TTNT is measured from the date of initiation of treatment to the start date of the next treatment regimen.
measure
Time to Next Treatment (TTNT)
time Frame
Up to 6.5 years
description
PFS is defined as the duration of time from start of study treatment to time of progression or death, whichever occurs first.
measure
Progression Free Survival (PFS)
time Frame
Up to 6.5 Years
description
Time to the best response recorded.
measure
Time to Best Response
time Frame
2 years
description
The percentage of people who are still alive.
measure
Overall Survival (OS) Rate
time Frame
Up to 6.5 Years
description
Total number of AEs observed.
measure
Number of Adverse Events (AEs)
time Frame
30 Days Post Last Dose, Up to approximately 9 months

Full study description

brief Summary: This study is designed to define dose-limiting toxicity and determine preliminary evidence of efficacy of carfilzomib (CFZ) in combination with bendamustine and dexamethasone for patients with newly diagnosed multiple myeloma (MM).
detailed Description: Multiple myeloma (MM) is a malignant plasma cell disorder resulting in approximately 11,000 deaths in the United States each year. It is estimated that between 60,000-80,000 people are currently under treatment for refractory or relapsed MM. Prognosis and survival have improved over the last 20 years, but the disease is still universally fatal despite efforts to develop new and more effective chemotherapeutic regimens. Therefore, new regimens need to be developed for patients prior to peripheral blood stem cell transplant and for those unable to tolerate the toxicity of transplant. An IRB-approved long-term retrospective chart review study (IRB-AAAU4389) was conducted to collect data for Outcome Measures relating to long-term analysis (up to 6.5 years).

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-06b674f115adfc1a34b4
requested nct id
NCT02002598
primary nct id
NCT02002598
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
payload sha256
fc9765fd634bfd671e97763cafad685eab80bfc9c04c8f2a1f6bb28951c3d4cb
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-06b674f115adfc1a34b4
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT02002598
occurrences
context exact
NCT02002598
end
11
exact text
NCT02002598
start
0
offset unit
unicode_code_points
query cond
Plasma Cell Neoplasms
query disease state id
ds-plasma-cell-neoplasms
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
source file sha256
2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
source json pointer
/studies/35/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
de5ec1af301906c11aeec874493b01936498ad0991e2d59d22cd2655966fd67d
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Plasma+Cell+Neoplasms&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice