NCT02148913 · REGISTRY CONDITION SEARCH

Phase I: Melphalan, Bendamustine and Carfilzomib for Autologous Transplant 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
Status at capture: COMPLETED
Registry last update: 2024-07-26

This is a phase I clinical trial. Patients with a diagnosis of multiple myeloma undergoing autologous transplantation will receive a preparative regimen of melphalan, bendamustine, and carfilzomib. We hypothesize that the addition of carfilzomib to a conditioning regimen of melphalan and bendamustine in the setting of autologous transplantation for multiple myeloma is feasible and safe.

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

Absence of Dose Limiting Toxicity

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outcome · POSTED

Neutrophil Engraftment

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outcome · POSTED

Platelet Engraftment

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outcome · POSTED

Response Rate

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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: Inclusion Criteria: * Diagnosis of multiple myeloma * At least 2 x 106 CD34+ cells/kg have been collected from the patient and cryopreserved for ASCT * Greater than 18 years * Karnofsky score greater than 70% * No evidence of progressive bacterial, viral, or fungal infection * Absolute neutrophil count above 1000 * Platelet count above 50,000 * Hemoglobin above 8 g/dL * Creatinine clearance greater than 50 mL/min * Total bilirubin, ALT, and AST less than 2 x the upper limit of normal * Alkaline phosphatase less than or equal to 250 IU/L * Left Ventricular Ejection Fraction (LVEF) greater than or equal to 45% * Adjusted Carbon Monoxide Diffusing Capacity (DLCO) greater than or equal to 60% * Negative HIV serology * Recovered from toxicity of previous chemotherapy (excludes grade 1 neurotoxicity and hematological toxicity) * Patients with a pre-transplant disease status consistent with a very good partial response (VGPR), partial response (PR), stable disease (SD), progressive disease (PD), or relapse from complete remission (CR). Exclusion Criteria: * Patients who are refractory to carfilzomib. Refractory is defined as disease progression while on carfilzomib therapy after receiving at least two cycles of treatment. * Patients with a complete response (CR) (including near CR and stringent CR) to conventional induction therapy and proceeding to transplantation. * Pregnant or nursing females or women of reproductive capability who are unwilling to use effective contraception. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 months in a row. * Male subjects who refuse to practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized (ie, post-vasectomy). * Patient with Grade 2 peripheral neuropathy * Inability to provide informed consent * Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. * Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant. * Known allergies to any of the components of the investigational treatment regimen or required ancillary treatments. * Serious medical or psychiatric illness likely to interfere with participation in this clinical study. * Diagnosed or treated for another malignancy within 3 years of enrollment (with the exception of non-melanoma skin cancer). * Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial. * Prisoner
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
intervention Names
Drug: Cohort 1: Carfilzomib 15 mg/m2
label
Cohort 1: Carfilzomib 15 mg/m2
type
ACTIVE_COMPARATOR
description
Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes.
intervention Names
Drug: Cohort 2: Carfilzomib 20 mg/m2
label
Cohort 2: Carfilzomib 20 mg/m2
type
ACTIVE_COMPARATOR
description
Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
intervention Names
Drug: Cohort 2b: Carfilzomib 20 mg/m2
label
Cohort 2b: Carfilzomib 20 mg/m2
type
ACTIVE_COMPARATOR
description
Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes.
intervention Names
Drug: Cohort 3b: Carfilzomib 27 mg/m2
label
Cohort 3: Carfilzomib 27mgm2
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Cohort 1: Carfilzomib 15 mg/m2
description
Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
name
Cohort 1: Carfilzomib 15 mg/m2
other Names
Carfilzomib - Kyprolis
Bendamustine - Treanda
Melphalan - Alkeran
type
DRUG
arm Group Labels
Cohort 2: Carfilzomib 20 mg/m2
description
Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
name
Cohort 2: Carfilzomib 20 mg/m2
other Names
Carfilzomib - Kyprolis
Bendamustine - Treanda
Melphalan - Alkeran
type
DRUG
arm Group Labels
Cohort 2b: Carfilzomib 20 mg/m2
description
Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
name
Cohort 2b: Carfilzomib 20 mg/m2
other Names
Carfilzomib - Kyprolis
Bendamustine - Treanda
Melphalan - Alkeran
type
DRUG
arm Group Labels
Cohort 3: Carfilzomib 27mgm2
description
Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
name
Cohort 3b: Carfilzomib 27 mg/m2
other Names
Carfilzomib - Kyprolis
Bendamustine - Treanda
Melphalan - Alkeran
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 18
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
Find the response rate of the combination of melphalan, bendamustine, and carfilzomib as a conditioning regimen in patients with multiple myeloma undergoing autologous transplantation.
measure
Response Rate
time Frame
Disease assessment at day +100, +180, and +365 (+/- 7 days).

primary Outcomes

description
An absence of neutrophil engraftment by Day +22, absence of platelet engraftment by Day +35, and any grade 4 GI toxicity or any \>/= grade 3 non-hematologic toxicity as defined by the common toxicity criteria, which is deemed by the DSMB as probably related to the study protocol.
measure
Absence of Dose Limiting Toxicity
time Frame
Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.

secondary Outcomes

description
Engraftment of Neutrophils: ANC recovery is defined as an absolute neutrophil count (ANC) of ≥ 0.5 x 109/L for three consecutive laboratory values obtained on different days. The day used as neutrophil engraftment is the date of the first of three laboratory values. Graft Failure: Graft failure includes failure to achieve neutrophil engraftment by day 22.
measure
Neutrophil Engraftment
time Frame
Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
description
Engraftment of Platelets: Platelet engraftment is defined as a platelet count ≥ 20 x 109/L for 3 consecutive measurements obtained on different days. The patient must not have received a platelet infusion for seven consecutive days prior to the first day being considered. The day used as platelet engraftment is the date of the first of three laboratory values.
measure
Platelet Engraftment
time Frame
Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.

Full study description

brief Summary: This is a phase I clinical trial. Patients with a diagnosis of multiple myeloma undergoing autologous transplantation will receive a preparative regimen of melphalan, bendamustine, and carfilzomib. We hypothesize that the addition of carfilzomib to a conditioning regimen of melphalan and bendamustine in the setting of autologous transplantation for multiple myeloma is feasible and safe.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice