Know Cancer

or
forgot password

Pharmacogenomic Study to Predict Survival, Best Response and Toxicity in Newly Diagnosed Myeloma Patients Above the Age of 65 Treated With Either a Combination of Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone


N/A
65 Years
N/A
Open (Enrolling)
Both
Myeloma

Thank you

Trial Information

Pharmacogenomic Study to Predict Survival, Best Response and Toxicity in Newly Diagnosed Myeloma Patients Above the Age of 65 Treated With Either a Combination of Melphalan-prednisone-thalidomide or Lenalidomide-dexamethasone


Inclusion Criteria:



- 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 3 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 one of the following):

- Calcium elevation in the blood (serum calcium > 10.5 mg/l or upper limit of
normal)

- Renal insufficiency (serum creatinine > 2 mg/dl)

- Anemia (hemoglobin < 10 g/dl or 2 g < normal)

- Lytic bone lesions or osteoporosis

- have measurable disease by protein electrophoresis analyses as defined by the
following:

- IgG multiple myeloma: Serum monoclonal paraprotein (M-protein)level ≥ 1.0 g/dL
or urine M-protein level ≥ 200 mg/24 h

- IgA multiple myeloma: Serum M-protein level ³ 0.5 mg/dL or urine M-protein
level³ 200 mg/24 h

- 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 Mprotein
level ≥ 200 mg/24h

- IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dL or urine M-protein level
≥ 200 mg/24h

- Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dL or urine Mprotein
level ≥ 200 mg/24 hours

- ECOG performance status of 0, 1, or 2

- Treated by either melphalan-prednisone-thalidomide or lenalidomide- dexamethasone

Exclusion Criteria:

- 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 randomization]

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

- Any of the following laboratory abnormalities :

- Absolute neutrophil count (ANC) < 1,000 cells/µL (1.0 x 109/L)

- Platelet count < 50,000 cells/µL (50 x 109/L) for patients in whom < 50% of bone
marrow nucleated cells are plasma cells; but platelet count < 30,000/µL for
patients in whom ≥ 50% of bone marrow nucleated cells are plasma cells

- Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)

- Creatinine clearance ≤ 30 mL/min (Cockroft-Gault calculation)

- Prior history of malignancies, other than multiple myeloma, unless the subject has
been free of the disease for ≥ 3 years. Exceptions include the following:

- Basal cell carcinoma of the skin

- Squamous cell carcinoma of the skin

- Carcinoma in situ of the cervix

- Carcinoma in situ of the breast

- Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)

- Patients who have are unable or unwilling to undergo antithrombotic therapy

- Peripheral neuropathy of > grade 2 severity

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

- Primary AL amyloidosis and myeloma complicated by amyloidosis.

- Renal failure requiring dialysis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Principal Investigator

Philippe MOREAU, Pr

Investigator Role:

Study Chair

Investigator Affiliation:

Departement of clinical Hematology (University Hospital of Nantes)

Authority:

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

Study ID:

IFM 2007-03

NCT ID:

NCT00907452

Start Date:

April 2009

Completion Date:

Related Keywords:

  • Myeloma
  • Pharmacogenomics
  • prediction response
  • prediction adverse event
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location