A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects (CHAMPION 2)

Amgen

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Carfilzomib; Drug: Cyclophosphamide; Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01980589

2012-003

Details and patient eligibility

About

The primary objective was to determine the maximum tolerated dose of carfilzomib given twice weekly in combination with cyclophosphamide and dexamethasone for patients with newly diagnosed multiple myeloma.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Newly diagnosed multiple myeloma

2. Measurable disease, as defined by 1 or more of the following

   • Serum M-protein ≥ 0.5 g/dL, or
   • Urine M-protein ≥ 200 mg/24 hours, or
   • In subjects without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal kappa lambda ( κ/λ) ratio

3. Males and females ≥ 18 years of age

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2

5. Adequate hepatic function

6. Left ventricular ejection fraction (LVEF) ≥ 40%

7. Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L

8. Platelet count ≥ 50 × 10^9/L

9. Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min

Exclusion criteria

1. Planned autologous hematopoietic stem cell transplantation (HSCT) for the initial therapy of newly diagnosed multiple myeloma
2. Multiple myeloma of immunoglobulin M (IgM) subtype
3. Prior systemic treatment for multiple myeloma
4. Glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds the equivalent of dexamethasone 160 mg
5. Known amyloidosis
6. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 6 months prior to enrollment.
7. Known human immunodeficiency virus (HIV) seropositive, hepatitis C infection, and/or hepatitis B (subjects with hepatitis B surface antigen [SAg] or core antibody receiving and responding to antiviral therapy directed at hepatitis B are allowed)
8. Significant neuropathy (Grades ≥ 2) within 14 days prior to enrollment
9. Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Carfilzomib, Cyclophosphamide and Dexamethasone (CCd)

Experimental group

Description:

Participants received carfilzomib, cyclophosphamide and dexamethasone for up to eight 28-day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.

Treatment:

Drug: Cyclophosphamide

Drug: Dexamethasone

Drug: Carfilzomib