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

NCT01812720 | Withdrawn Phase 2

• 4 other identifiers: MC1287NCI-2013-0049212-005975P30CA015083
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma

Outcome Measures

Primary Outcomes (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.

  Up to 5 years

Secondary Outcomes (5)

• Overall survival

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

• Progression-free survival

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

• Time to progression post SCT

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

• Time to progression post SCT

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

• Maximum grade for each type of adverse event

  Up to 30 days after last day of treatment

Study Arms (1)

Treatment (carfilzomib, dexamethasone)

EXPERIMENTAL

Patients 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.

Drug: carfilzomib; Drug: dexamethasone; Other: laboratory biomarker analysis

Interventions

carfilzomib DRUG

Given IV

Also known as: Kyprolis, PR-171

Treatment (carfilzomib, dexamethasone)

dexamethasone DRUG

Given PO

Also known as: Aeroseb-Dex, Decaderm, Decadron, DM, DXM

Treatment (carfilzomib, dexamethasone)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (carfilzomib, dexamethasone)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

City of Hope

Duarte, California, 91010, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

carfilzomib; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Shaji Kumar

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 18, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 19, 2016

Record last verified: 2016-01

Locations

US (3)