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


Phase 2
18 Years
N/A
Not Enrolling
Both
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

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Trial Information

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


PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. 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:

I. 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.


Inclusion Criteria:



- Creatinine =< 3 mg/dL

- Absolute neutrophil count >= 1,000/μL

- Platelet count >= 75,000/μL

- Hemoglobin >= 8.0 g/dL

- Diagnosis of symptomatic multiple myeloma (MM)

- Received single autologous stem cell transplantation 60-120 days prior to
registration

- 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 the Mayo Clinic enrolling institution 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

- Bone marrow plasma cells >= 30%

- For patients with no relapse prior to transplant, measurable disease at the time of
diagnosis

- 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

- 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

Exclusion Criteria:

- 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

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of complete response

Outcome Description:

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.

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Shaji Kumar, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

MC1287

NCT ID:

NCT01812720

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Mayo ClinicRochester, Minnesota  55905