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Refractory Multiple MyelomaPhase 2CARAMEL 2NCT01812720

Carfilzomib and Dexamethasone in Treating Patients With Multiple Myeloma Who Previously Underwent a Stem Cell Transplant

A Phase 2 study testing carfilzomib, dexamethasone and laboratory biomarker analysis in people with Refractory Multiple Myeloma and Stage I Multiple Myeloma, run by Mayo Clinic at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II trial studies how well carfilzomib and dexamethasone work in treating patients with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
carfilzomib, dexamethasone and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
3 sitesUnited States
Study dates
Aug 2013to Oct 2014
Phase
Phase 2
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

  • Creatinine =< 3 mg/dL
  • Absolute neutrophil count >= 1,000/uL
  • Platelet count >= 75,000/uL
  • Hemoglobin >= 8.0 g/dL
  • Previous diagnosis of symptomatic multiple myeloma (MM)
  • Received single autologous stem cell transplantation 60-120 days prior to registration
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  • Received the autologous SCT =< 12 months of their diagnosis of myeloma to be eligible for the study
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Recovered from toxicity of previous chemotherapy (excludes grade 1 neurotoxicity and hematological toxicity)
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that the subject may withdraw consent at any time without prejudice to future medical care
  • Negative pregnancy test performed =< 7 days prior to registration, for women of childbearing potential only
  • Willingness to return to one of the enrolling institutions for follow-up (during the active monitoring phase of the study); NOTE: during the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up
  • Measurable disease of multiple myeloma at the time of baseline values for disease assessment as defined by at least one of the following:
  • Serum monoclonal protein >= 1.0 g/dL
  • >= 200 mg of monoclonal protein in the urine on 24 hour electrophoresis
  • Serum immunoglobulin free light chain >= 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
  • NOTE: for patients with no relapse prior to transplant, measurable disease at the time of diagnosis
  • NOTE: for patients who have had a disease relapse prior to transplant, measurable disease at the time of the most recent relapse immediately prior to transplant; NOTE: if the patient had treatment for the relapsed disease prior to transplant, the patient must have measurable disease at the time of relapse prior to this therapy
  • Willing to provide bone marrow and blood samples for correlative research purposes

Who cannot join

  • Prior allogeneic bone marrow/peripheral blood stem cell transplant
  • Evidence of disease progression post SCT at the time of consideration for the study enrollment
  • Myocardial infarction =< 6 months prior to registration
  • New York Heart Association (NYHA) class III or IV heart failure
  • Uncontrolled angina
  • Severe uncontrolled ventricular arrhythmias
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  • Electrocardiographic (ECG) evidence of acute ischemia or active conduction system abnormalities; NOTE: prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant
  • Seroreactivity for human immunodeficiency virus (HIV), human T-cell lymphotrophic virus (HTLV) I or II, hepatitis B virus (HBV), or hepatitis C virus (HCV)
  • Other active malignancy requiring therapy; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer
  • Pregnant women or women of reproductive capability who are unwilling to use effective contraception
  • Nursing women
  • Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 28 days after stopping treatment
  • Other co-morbidity, which would interfere with patient's ability to participate in the trial, e.g. uncontrolled infection, uncompensated lung disease
  • Concurrent chemotherapy, radiotherapy, or any ancillary therapy considered investigational; NOTE: bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
  • Known allergies to any of the components of the investigational treatment regimen or required ancillary treatments

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • City of Hope

    Duarte, California, 91010

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase 2 Trial of Carfilzomib Consolidation After Autologous Stem Cell Transplantation for Multiple Myeloma(CARAMEL 2)

This phase II trial studies how well carfilzomib and dexamethasone work in treating patients with multiple myeloma who previously underwent a stem cell transplant. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as dexamethasone, may improve bone marrow function and increase blood cell counts. Giving carfilzomib together with dexamethasone may be an effective treatment for multiple myeloma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the complete response (CR) rate with carfilzomib and dexamethasone consolidation following an upfront single stem cell transplant (SCT).

SECONDARY OBJECTIVES:

  1. To assess the toxicity of carfilzomib and dexamethasone when used as consolidation therapy in patients post SCT.

II. To determine the progression free rate at 1 and 2 years post SCT. III. To evaluate progression-free survival and overall survival.

TERTIARY OBJECTIVES:

  1. To determine the proportion of patients achieving a minimal residual disease (MRD) negative status.

II. To assess the HevyLite assay prior to and during treatment.

OUTLINE:

Patients receive carfilzomib intravenously (IV) over 30 minutes and dexamethasone orally (PO) on days 1, 2, 15, and 16. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 3 years and then every 6 months for 2 years.

Being tested
carfilzomib, dexamethasone, laboratory biomarker analysis
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 Kyprolis, PR-171

    Given IV

  • dexamethasoneDrug

    Also called Aeroseb-Dex, Decaderm, Decadron, DM

    Given PO

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01812720
Study groupRoleWhat they receive
Treatment (carfilzomib, dexamethasone)ExperimentalPatients receive carfilzomib IV over 30 minutes and dexamethasone PO on days 1, 2, 15, and 16. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: carfilzomib; Drug: dexamethasone; Other: laboratory biomarker analysis

What is being measured

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

  1. Rate of complete response

    The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.

    Measured: Up to 5 years

Secondary outcomes (5)

  1. Overall survival

    The distribution of survival time will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to death due to any cause, assessed up to 5 years

  2. Progression-free survival

    The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to progression or death due to any cause, assessed up to 5 years

  3. Time to progression post SCT

    The distribution of time to progression will be estimated using the method of Kaplan-Meier.

    Measured: Time from SCT to the earliest day with documentation of disease progression, assessed at 1 year post-SCT

  4. Time to progression post SCT

    The distribution of time to progression will be estimated using the method of Kaplan-Meier.

    Measured: Time from SCT to the earliest day with documentation of disease progression, assessed at 2 years post-SCT

  5. Maximum grade for each type of adverse event

    Frequency tables will be reviewed to determine adverse event patterns.

    Measured: Up to 30 days after last day of treatment

Timeline

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

  1. First posted18 Mar 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionSep 2014
  4. Study completionOct 2014

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01812720
Sponsor's protocol ID
MC1287
Other IDs
NCI-2013-00492, 12-005975, MC1287, P30CA015083
Acronym
CARAMEL 2
Status last verified
Jan 2016
First submitted
14 Mar 2013
Last updated
19 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carfilzomib, dexamethasone and laboratory biomarker analysis in people with Refractory Multiple Myeloma and Stage I Multiple Myeloma, run by Mayo Clinic at 3 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 15 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: withdrawn, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Rate of complete response (time frame: Up to 5 years). 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 NCT01812720.

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 19 Dec 2016.

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