Multiple MyelomaPhase 1NCT02148913
Phase I: Melphalan, Bendamustine and Carfilzomib for Autologous Transplant in Multiple Myeloma
A Phase 1 study testing Cohort 1: Carfilzomib 15 mg/m2, Cohort 2: Carfilzomib 20 mg/m2 and Cohort 2b: Carfilzomib 20 mg/m2 in people with Multiple Myeloma, run by Corewell Health West at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Cohort 1: Carfilzomib 15 mg/m2, Cohort 2: Carfilzomib 20 mg/m2 and Cohort 2b: Carfilzomib 20 mg/m2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2018
- Phase
- Phase 1
- 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
- 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
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- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Melphalan, Bendamustine, and Carfilzomib for Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma
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.
- Conditions
- Multiple Myeloma
- Being tested
- Cohort 1: Carfilzomib 15 mg/m2, Cohort 2: Carfilzomib 20 mg/m2, Cohort 2b: Carfilzomib 20 mg/m2, Cohort 3b: Carfilzomib 27 mg/m2
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort 1: Carfilzomib 15 mg/m2Drug
Also called Carfilzomib - Kyprolis, Bendamustine - Treanda, Melphalan - Alkeran
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
Cohort 2: Carfilzomib 20 mg/m2Drug
Also called Carfilzomib - Kyprolis, Bendamustine - Treanda, Melphalan - Alkeran
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
Cohort 2b: Carfilzomib 20 mg/m2Drug
Also called Carfilzomib - Kyprolis, Bendamustine - Treanda, Melphalan - Alkeran
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
Cohort 3b: Carfilzomib 27 mg/m2Drug
Also called Carfilzomib - Kyprolis, Bendamustine - Treanda, Melphalan - Alkeran
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
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Carfilzomib 15 mg/m2 | Active comparator | Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Receives: Drug: Cohort 1: Carfilzomib 15 mg/m2 |
| Cohort 2: Carfilzomib 20 mg/m2 | Active comparator | Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Receives: Drug: Cohort 2: Carfilzomib 20 mg/m2 |
| Cohort 2b: Carfilzomib 20 mg/m2 | Active comparator | Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Receives: Drug: Cohort 2b: Carfilzomib 20 mg/m2 |
| Cohort 3: Carfilzomib 27mgm2 | Active comparator | Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Receives: Drug: Cohort 3b: Carfilzomib 27 mg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of Dose Limiting Toxicity
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.
Measured: Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
Secondary outcomes (2)
Neutrophil Engraftment
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.
Measured: Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
Platelet Engraftment
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.
Measured: Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muneer H Abidi, MD, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148913
- Sponsor's protocol ID
- 2014-067
- Status last verified
- Feb 2024
- First submitted
- 23 May 2014
- Last updated
- 26 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Melphalan, Bendamustine, and Carfilzomib for Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02148913
- Acronym / sponsor ID
- 2014-067
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 26 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Carfilzomib 15 mg/m2 | Active comparator | Drug: Cohort 1: Carfilzomib 15 mg/m2Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. |
| Cohort 2: Carfilzomib 20 mg/m2 | Active comparator | Drug: Cohort 2: Carfilzomib 20 mg/m2Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. |
| Cohort 2b: Carfilzomib 20 mg/m2 | Active comparator | Drug: Cohort 2b: Carfilzomib 20 mg/m2Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes. |
| Cohort 3: Carfilzomib 27mgm2 | Active comparator | Drug: Cohort 3b: Carfilzomib 27 mg/m2Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohort 1: Carfilzomib 15 mg/m2Also: Carfilzomib - Kyprolis, Bendamustine - Treanda, Melphalan - AlkeranCarfilzomib 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 | Drug | Cohort 1: Carfilzomib 15 mg/m2 |
| Cohort 2: Carfilzomib 20 mg/m2Also: Carfilzomib - Kyprolis, Bendamustine - Treanda, Melphalan - AlkeranCarfilzomib 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 | Drug | Cohort 2: Carfilzomib 20 mg/m2 |
| Cohort 2b: Carfilzomib 20 mg/m2Also: Carfilzomib - Kyprolis, Bendamustine - Treanda, Melphalan - AlkeranCarfilzomib 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 | Drug | Cohort 2b: Carfilzomib 20 mg/m2 |
| Cohort 3b: Carfilzomib 27 mg/m2Also: Carfilzomib - Kyprolis, Bendamustine - Treanda, Melphalan - AlkeranCarfilzomib 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 | Drug | Cohort 3: Carfilzomib 27mgm2 |
Primary outcome
Absence of Dose Limiting Toxicity
Time frame: Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
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.
2 secondary outcomes
Neutrophil Engraftment
Time frame: Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
Platelet Engraftment
Time frame: Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muneer H Abidi, MD principal investigator
Corewell Health West
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cohort 1: Carfilzomib 15 mg/m2, Cohort 2: Carfilzomib 20 mg/m2 and Cohort 2b: Carfilzomib 20 mg/m2 in people with Multiple Myeloma, run by Corewell Health West at 1 site in United States.
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 16 inclusion and 13 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 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 26 Jul 2024). 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?
Absence of Dose Limiting Toxicity (time frame: Assessed daily (while inpatient) through clinical and laboratory examinations up to 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2024.