Multiple MyelomaPhase 111-MM-01NCT01660750

A Safety Study of Carfilzomib, Cyclophosphamide & Dexamethasone Prior to ASCT in Patients With Newly Diagnosed Myeloma

A Phase 1 study testing Carfilzomib, Cyclophosphamide and Dexamethasone in people with Multiple Myeloma, run by Criterium, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Carfilzomib, Cyclophosphamide and Dexamethasone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 5 sitesUnited States
Study dates: Jan 2013to Dec 2015
Phase: Phase 1
Are there results?: None posted in the registry

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

Cytopathologically or histologically confirmed diagnosis of MM
Measurable disease, as indicated by one or more of the following:
Serum M-protein ≥ 1.0 g/dL
Urine Bence Jones protein ≥ 200 mg/24 hr
Elevated Free Light Chain as per the International Myeloma Working Group (IMWG) criteria
Males and females ≥ 18 years of age

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Life expectancy of more than 5 months
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Adequate hepatic function, with bilirubin < 2 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.5 times ULN
Serum Creatinine Clearance(CrCl) ≥ 30 mL/min, either measured or calculated using a standard formula (e.g. Cockcroft and Gault)
Additional Laboratory Requirements
Absolute neutrophil count (ANC) ≥1.0 x 109/L
Hemoglobin ≥8 g/dL [transfusion permitted]
Platelet count ≥50.0 x 109/L
Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks
Patients may receive RBC or platelet transfusions, if clinically indicated, in accordance with institutional guidelines
Written informed consent in accordance with federal, local, and institutional guidelines
Patients must agree to practice contraception
Male patients must agree not to donate semen or sperm.

Who cannot join

Patients with non-secretory or hyposecretory MM
Prior treatment for MM (prior radiation therapy or dexamethasone up to 160 mg for spinal cord compression is allowed. Other limited field radiation involving ≤ 1/3 of the pelvic area is also allowed)
Plasma cell leukemia
Pregnant or lactating females
Major surgery within 21 days prior to first dose
Congestive heart failure (CHF) (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction in the previous six months

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Acute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first dose
Patients receiving active treatment or intervention for any other malignancy or patients who, at the Investigator's discretion, may require active treatment or intervention for any other malignancy within 8 months of starting study treatment.
Serious psychiatric or medical conditions that could interfere with treatment
Significant neuropathy (Grade 3, Grade 4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before study treatment
Contraindication to any of the required concomitant drugs, including antiviral (e.g. Valacyclovir) and proton-pump inhibitor (e.g. lansoprazole). Corticosteroid therapy in a dose equivalent to dexamethasone ≥ 1.5 mg/day or prednisone ≥ 10 mg/day. (Steroid use is allowed if necessary to treat spinal cord compression and/or hypocalcaemia.)
Patients in whom the required program of oral and IV fluid hydration is contraindicated, e.g. due to pre-existing pulmonary, cardiac, or renal impairment
Patients with primary systemic amyloidosis.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Duke University Medical Center
Durham, North Carolina, 27710
Samuel Oschin Comprehensive Cancer Center at Cedars-Sinai Medical Center
Los Angeles, California, 90048
Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, 92262
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
University of Massachusettes Memorial
Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Multi-Center Phase Ib, Open-Label, Dose-Finding Pilot Study to Evaluate the Combination of Carfilzomib and Cyclophosphamide With Dexamethasone Prior to ASCT in Patients With Transplant Eligible Newly Diagnosed Myeloma

Read the detailed description

This is a dose finding pilot study to evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and cyclophosphamide with dexamethasone (Car-Cy-Dex) prior to autologous stem cell transplant (ASCT) in patients with newly diagnosed transplant eligible multiple myeloma. The study will also explore the efficacy of Car-Cy-Dex including overall response after induction therapy, overall response at 3 and 6 months post ASCT, and time to progression, progression free survival, and time to next therapy if it occurs within 6 months post ASCT.

Conditions: Multiple Myeloma
Being tested: Carfilzomib, Cyclophosphamide, Dexamethasone
Keywords: newly diagnosed multiple myeloma, transplant eligible multiple myeloma
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CarfilzomibDrug
Also called PR-171, Kyprolis
IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days
CyclophosphamideDrug
Also called Cytoxan
PO on days 1, 8, and 15 every 28 days
DexamethasoneDrug
Also called Decadron
40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.

Study groups in NCT01660750
Study group	Role	What they receive
Carfilzomib, Cyclophosphamide, Dexamethasone	Experimental	All eligible subjects will receive Carfilzomib, Cyclophosphamide, and Dexamethasone. Receives: Drug: Carfilzomib; Drug: Cyclophosphamide; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events as a measure of safety and tolerability
Review of adverse events for safety and to determine the maximum tolerated dose of the combination treatment.
Measured: Throughout treatment, estimated to be 4-6 months per patients

Secondary outcomes (5)

Overall Response after induction therapy
Overall response (PR, VGPR, CR, sCR)
Measured: Every 28 days during induction therapy, estimated to be 4-6 months
Overall Response post ASCT
Overall Response (PR, VGPR, CR, sCR) at 3 and 6 months post ASCT.
Measured: 3 and 6 months post ASCT
Time to Progression
Time to progression will be noted if it occurs within 6 months post ASCT.
Measured: Througout treatment and 3 and 6 months post ASCT
Progression Free Survival
Measured: up to 6 months post ASCT
Time to Next Therapy
Time to Next Therapy if occurs within 6 months post ASCT
Measured: up to 6 months post ASCT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Dec 2015

First posted9 Aug 2012 (estimated)
Study startJan 2013
Primary completionAug 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01660750
Sponsor's protocol ID: AMyC 11-MM-01
Other IDs: CAR-IST-520
Acronym: 11-MM-01
Status last verified: Oct 2017
First submitted: 7 Aug 2012
Last updated: 18 Oct 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center Phase Ib, Open-Label, Dose-Finding Pilot Study to Evaluate the Combination of Carfilzomib and Cyclophosphamide With Dexamethasone Prior to ASCT in Patients With Transplant Eligible Newly Diagnosed Myeloma
ClinicalTrials.gov ID: NCT01660750
Acronym / sponsor ID: 11-MM-01 / AMyC 11-MM-01
Conditions: Multiple Myeloma
Keywords: newly diagnosed multiple myeloma, transplant eligible multiple myeloma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Criterium, Inc.Industry (pharma, biotech, devices)
Collaborators: Amgen
Study start: Jan 2013
Primary completion: Aug 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 9 Aug 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Carfilzomib, Cyclophosphamide, Dexamethasone	Experimental	Drug: Carfilzomib, Drug: Cyclophosphamide, Drug: DexamethasoneAll eligible subjects will receive Carfilzomib, Cyclophosphamide, and Dexamethasone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Cytopathologically or histologically confirmed diagnosis of MM
Measurable disease, as indicated by one or more of the following:
Serum M-protein ≥ 1.0 g/dL
Urine Bence Jones protein ≥ 200 mg/24 hr
Elevated Free Light Chain as per the International Myeloma Working Group (IMWG) criteria

Key exclusion criteria (13 listed)

Patients with non-secretory or hyposecretory MM
Prior treatment for MM (prior radiation therapy or dexamethasone up to 160 mg for spinal cord compression is allowed. Other limited field radiation involving ≤ 1/3 of the pelvic area is also allowed)
Plasma cell leukemia
Pregnant or lactating females
Major surgery within 21 days prior to first dose

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
CarfilzomibAlso: PR-171, KyprolisIV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days	Drug	Carfilzomib, Cyclophosphamide, Dexamethasone
CyclophosphamideAlso: CytoxanPO on days 1, 8, and 15 every 28 days	Drug	Carfilzomib, Cyclophosphamide, Dexamethasone
DexamethasoneAlso: Decadron40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.	Drug	Carfilzomib, Cyclophosphamide, Dexamethasone

Primary outcome

Adverse Events as a measure of safety and tolerability
Time frame: Throughout treatment, estimated to be 4-6 months per patients
Review of adverse events for safety and to determine the maximum tolerated dose of the combination treatment.

5 secondary outcomes

Overall Response after induction therapy
Time frame: Every 28 days during induction therapy, estimated to be 4-6 months
Overall Response post ASCT
Time frame: 3 and 6 months post ASCT
Time to Progression
Time frame: Througout treatment and 3 and 6 months post ASCT
Progression Free Survival
Time frame: up to 6 months post ASCT
Time to Next Therapy
Time frame: up to 6 months post ASCT

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
Individual participant dataSharing planned: Undecided

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

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.

Jatin Shah, MD principal investigator

AMyC

Brian GM Durie, MD principal investigator

AMyC

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Carfilzomib, Cyclophosphamide and Dexamethasone in people with Multiple Myeloma, run by Criterium, Inc. at 5 sites 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 19 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 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Adverse Events as a measure of safety and tolerability (time frame: Throughout treatment, estimated to be 4-6 months per patients). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01660750.

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 18 Oct 2017.