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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
Not Enrolling
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)


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


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.


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.


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

- 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

- 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

- 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

- 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:


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:


Principal Investigator

Shaji Kumar, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




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



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