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Phase 2
Open (Enrolling)
Multiple Myeloma

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Trial Information

Patients included in the study will receive a 6 week cycle consisting of Bendamustine
administered IV at doses of 90 mg/m2 on days 1 and 4 of the first cycle and days 1 and 8 in
subsequent cycles in combination with Bortezomib as a bolus dose of 1.3 mg/m2 on days 1, 4,
8, 11, 22, 25, 29 and 32, and oral prednisone at doses of 60 mg/m2, during the first four
days of each cycle.

Then, patients will receive eight additional cycles of 5-week . The same pattern consisting
of bendamustine and prednisone but bortezomib is administered as an intravenous bolus dose
of 1.3 mg/m2 on days 1, 8, 15 and 22.

Inclusion Criteria:

- Patient age greater than or equal to 18 at the time of signing Informed consent

- Patient who has voluntarily signed informed consent before conduct of the trial any
evidence that is not part of care normal patients, with the knowledge of the patient
that can leave the trial at any time he want

- Patient able, in the opinion of the physician to comply with the visitation schedule
and other requirements of the protocol

- Patient newly diagnosed symptomatic multiple myeloma based on standard criteria and
has not received any previous treatment of chemotherapy for MM.

- Patients with newly diagnosed multiple myeloma, secretory, or oligosecretor or not
secretor if it has soft tissue plasmacytomas.

- Patients with non-secretory MM oligosecretor or without white tissue plasmacytomas be
excluded to keep a group of patients with characteristics similar to the previous
study with which we compare the results.

- Patients with measurable disease, defined by the following criteria:

For MM secreting measurable disease is defined as any value quantifiable serum monoclonal
protein (≥ 1g/dl) and where applicable, a light chain excretion in urine ≥ 200 mg/24
hours. For Multiple Myeloma oligosecretor or secreting measurable disease defined by the
presence of soft tissue plasmacytomas (not bone) determined by clinical examination or
radiographic methods (eg MRI, CT-Scan)

- ECOG PS ≤ 2

- Expectations of life than 3 months.

- The patient has the following laboratory values ​​within 28 days before the baseline

Platelet count ≥ 100 x 109 / L, hemoglobin ≥ 8.0g/dL and absolute neutrophil count (ANC) ≥
1.5 x 109 / L; allowed counts under if they are clearly due to a bone marrow infiltration
by MM.

Corrected serum calcium <14mg/dL. Aspartate transaminase (AST) ≤ 2.5 x upper limit of
normal(LSN) Alanine aminotransferase (ALT) ≤ 2.5 x ULN Total bilirubin within normal
limits Serum creatinine <2 mg / dL

- Patients of childbearing potential must use effective contraception during duration of
the study and up to 6 months after completion of treatment

Exclusion Criteria:

- Patient has previously received treatment for multiple myeloma with Pulse steroids
except for some emergency that requires it before start of induction therapy,
administration of bisphosphonates or radiation therapy, or analgesic due to the
presence of plasmacytomas, which require it for some urgency.

- Patients with non-measurable disease.

- Patient with peripheral neuropathy grade ³ 2 within 14 days prior to its inclusion
in the trial

- Patients with hypersensitivity to bortezomib, boric acid, or bendamustine mannitol

- Patient to be known carrier of the virus HIV (human immunodeficiency) surface antigen
of hepatitis B virus or who has active infection virus hepatitis C.

- Patient who has had a myocardial infarction within 6 months prior to inclusion in the
clinical trial or has a functional class III or IV according to the New York Heart
Association (NYHA) heart failure, uncontrolled angina, uncontrolled ventricular
arrhythmias or acute ischemia detected electrocardiographically or conduction system

- Patient who has received any investigational agent within 30 days prior their
inclusion or is currently in another clinical trial or receiving any investigational

- Patient undergoing major surgery within 30 days before inclusion in the study

- Patient pregnant or breastfeeding

- Patients with acute diffuse infiltrative pulmonary disease and / or disease

- History of other malignancies after different myeloma (except for basal or squamous
cell carcinoma of the skin or carcinoma in situ of the cervix or breast) to unless
the patient is free of the disease beyond 5 years

- Hypertension arterial or poorly controlled diabetes mellitus or any other disease
severe organ involving an unreasonable risk to the patient

- Any psychiatric disorder that interferes with comprehension of consent informed or
prevent the normal discharge that requires participation in this trial

- Patients with major psychiatric history.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy in terms of response rate and complete response rate (CR and near CR)

Outcome Time Frame:

1 year

Safety Issue:



Spain: Ministry of Health

Study ID:




Start Date:

July 2011

Completion Date:

December 2014

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell