Know Cancer

forgot password

Phase I/II Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma.

Phase 1/Phase 2
65 Years
Open (Enrolling)

Thank you

Trial Information

Phase I/II Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma.

The primary objectives of this phase I/II study are to identify the most appropriate dose of
Carfilzomib in combination with a standard MP treatment regimen (phase I) and to evaluate
the efficacy of Carfilzomib plus MP (CMP) in terms of overall response rate [(ORR),
consisting of complete response (CR), very good partial response (VGPR), and partial
response (PR) (phase II)]. Phase I/II single arm open label

Inclusion Criteria:

- Karnofsky performance status (KPS) of at least 60%

- Life expectancy of more than 3 months.

- Must understand and voluntarily sign an informed consent form

- Age >65 years at the time of signing consent

- Previously untreated, symptomatic multiple myeloma as defined by the 2 criteria
below:○ MM diagnostic criteria (all 3 required):· Monoclonal plasma cells in the bone
marrow ≥10% and/or presence of a biopsy-proven plasmacytoma· Monoclonal protein
present in the serum and/or urine· Myeloma-related organ dysfunction (at least 1 of
the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/L or upper
limit of normal)[R] Renal insufficiency (serum creatinine > 2 mg/dL)[A] Anemia
(hemoglobin <10 g/dL or 2 g < normal)[B] Lytic bone lesions or osteoporosisAND have
measurable disease by protein electrophoresis analyses as defined by one or more of
the following:· IgG multiple myeloma: Serum monoclonal paraprotein (M protein) level
by SPEP ³ 0.5 g/dL or urine M-protein level ³ 200 mg/24 hours· IgA multiple myeloma:
Serum M-protein level ³ 0.5 mg/dL or urine M-protein level ³ 200 mg/24 hours· IgM
multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey
plain films): Serum M-protein level ≥ 1.0 g/dL or urine M-protein level ≥ 200 mg/24
hours· IgD multiple myeloma: Serum M-protein level ³ 0.05 g/dL or urine M-protein
level ³ 200 mg/24 hours Light chain multiple myeloma: Patients with serum free light
chain disease in whom the involved light chain measures ≥ 10 mg/dL

- ECOG performance status of 0, 1, or 2

- Able to adhere to the study visit schedule and other protocol requirements

- Affiliation number to National Health Care System

Exclusion Criteria:

- Patients are ineligible if they meet any of the following criteria: 1 Previous
treatment with antimyeloma therapy (does not include radiotherapy, bisphosphonates,
or a single short course of steroid [i.e., less than or equal to the equivalent of
dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not
have been given within 28 days (4 weeks) of consent]).

- Any serious medical condition that places the patient at an unacceptable risk if he
or she participates in this study.

- Female of childbearing potential

- Any of the following laboratory abnormalities:· Absolute neutrophil count (ANC) <
1,000 cells/mL (1.0 × 109/L) · Platelet count < 50,000 cells/mL (50 × 109/L) for
patients in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet
count <30,000 cells/mL for patients in whom ³ 50% of bone marrow nucleated cells are
plasma cells · Serum SGPT/ALT > 3.0 × upper limit of normal (ULN); Bilirubin >2 × ULN
[ALT more specific to liver]· Creatinine clearance ≤ 30 mL/min (Cockcroft-Gault
calculation)5 Prior history of malignancies, other than multiple myeloma, unless the
subject has been free of the disease for ³ 3 years. Exceptions include the
following:o Basal cell carcinoma of the skin Squamous cell carcinoma of the skin
Carcinoma in situ of the cervix Carcinoma in situ of the breast6 Incidental
histological finding of prostate cancer (TNM stage of T1a or T1b) Peripheral
neuropathy of > grade 2 severity.

- Known HIV positivity or active infectious hepatitis, type A, B, or C.

- Myocardial infarction within 3 months of enrollment, unstable angina within 2 months
or New York Heart Association class III or IV heart failure.

- Oral or IV fluid hydration contraindicated

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: determination of MTD by evaluation of hematological and non hematological toxicity

Safety Issue:


Principal Investigator

Philippe Moreau

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Nantes


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

October 2010

Completion Date:

December 2013

Related Keywords:

  • Myeloma
  • newly-diagnosed multiple myeloma.
  • Multiple Myeloma
  • Neoplasms, Plasma Cell