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Bendamustine Plus Bortezomib Plus Dexamethasone in the Treatment of Stage II/III Relapsed or Refractory Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma, Bendamustine, Bortezomib, Dexamethasone

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Trial Information

Bendamustine Plus Bortezomib Plus Dexamethasone in the Treatment of Stage II/III Relapsed or Refractory Multiple Myeloma

After relapse after or early progression on first-line treatment the prognosis of multiple
myeloma patients is unfavourable, with no remaining chance for cure. Therefore the search
for new treatment regimens, including drugs with novel, and different, mechanisms of action
is mandatory.

Both bendamustine and bortezomib are not yet established parts of standard first-line
regimens, but showed to have high activity both in chemo-naïve and pre-treated patients. The
novel mechanism of action of the proteasome inhibitor and the non-cross resistance of
bendamustine to other alkylating agents established in the first-line treatment of multiple
myeloma seem to recommend a combination of the two drugs for salvage therapy. The promising
response data in a series of relapsing MM patients treated with bendamustine, bortezomib and
prednisone support this assumption, as well as the feasibility and tolerability of the

In summary, there is some evidence for a favourable risk/benefit ratio for the combination
of bendamustine, bortezomib and a glucocorticoid drug, warranting the exploration in a
larger, prospectively designed multicenter phase II study.

Inclusion Criteria:

- Age min. 18 years at the time of signing the informed consent form

- Life expectancy of at least 3 months

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

- Measurable disease, defined as any quantifiable monoclonal protein value, defined by
at least one of the following three measurements: Serum M-protein ≥ 10g/l; Urine
light-chain (M-protein) of ≥ 200 mg/24 hours; Serum FLC assay: involved FLC level ≥10
mg/dl provided sFLC ratio is abnormal

- Relapsed or refractory MM in stage II or III after autologous SCT or conventional
chemotherapy (histologically or cytologically proven/ Salmon and Durie criteria) in
need of therapy

- All previous cancer therapy, including cytostatic therapy and surgery, must have been
discontinued at least 4 weeks prior to treatment in this study, except corticosteroid
therapy (dosage 40 to max. 160mg). Localised radiation therapy is allowed, but the
increased risk of leukocytopenia, erythrocytopenia and thrombocytopenia based on the
combination of a polychemotherapy and radiation therapy has to be considered and a
close monitoring of the patients has to be assured.

- ECOG performance status of 0-2 at study entry

- Laboratory test results within these ranges:

- Absolute neutrophil count min. 1.5 x 109/L

- Platelet count min. 75 x 109/L

- Total bilirubin max. 1.5 mg/dL

- AST (SGOT) and ALT (SGPT) max. 2 x ULN or max. 5 x ULN if hepatic lesions are

- Disease free of prior malignancies for min. 5 years with exception of curatively
treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of
the cervix or breast

- Fertile patients must use effective contraception during and for 6 months after study

No study treatment or any other procedure within the framework of the trial (except for
screening) will be performed in any patient prior to receipt of written informed consent.

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form

- Pregnant or breast feeding females

- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.

- Peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as defined
by NCI CTCAE, version 3.0.

- Use of any other experimental drug or therapy within 28 days of pre-study visit.

- Known hypersensitivity to the study drugs

- Any prior use of bortezomib or bendamustine in the last six months

- Concurrent use of other anti-cancer agents or treatments other than those stated in
this treatment plan

- Known positive for HIV or infectious hepatitis, type A, B or C

- Active, uncontrolled infections

- Acute diffuse infiltrative pulmonary disease and pericardial disease.

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Description:

evaluation of the overall response rate (sCR + CR + VGPR + PR + MR)

Outcome Time Frame:

8 cycles à 28 days plus follow-up phase

Safety Issue:


Principal Investigator

Heinz P. Ludwig, Univ. Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wilhelminenspital Vienna


Austria: Agency for Health and Food Safety

Study ID:




Start Date:

June 2010

Completion Date:

June 2014

Related Keywords:

  • Multiple Myeloma
  • Bendamustine
  • Bortezomib
  • Dexamethasone
  • multiple myeloma
  • bendamustine
  • bortezomib
  • dexamethasone
  • Multiple Myeloma
  • Neoplasms, Plasma Cell