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A Phase II Study of Bendamustine, Velcade and Dexamethasone (BVD) in the Treatment of Elderly Patients (>= 65 Years) With Multiple Myeloma in 1st Relapse or Refractory to 1st Line Therapy

Phase 2
65 Years
Open (Enrolling)
Multiple Myeloma

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Trial Information

A Phase II Study of Bendamustine, Velcade and Dexamethasone (BVD) in the Treatment of Elderly Patients (>= 65 Years) With Multiple Myeloma in 1st Relapse or Refractory to 1st Line Therapy

After relapse or after early progression on first-line treatment, the prognosis of multiple
myeloma (MM) patients is unfavourable, and the search for new treatment regimens, including
drugs with novel mechanisms of action is essential.

Bendamustine and bortezomib have shown high activity boch in first-line regimens 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 (second-line regimen). Finally, 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 combination.

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

Inclusion Criteria:

- Symptomatic multiple myeloma (MM) patient at the time of diagnosis (but not
necessarily at the time of relapse), according to International Myeloma Working Group

- Patient having received conventional chemotherapy in 1st line treatment because of
age 65 years or over, or younger than 65 years and ineligible to high-dose therapy
plus stem cell transplantation.

- Measurable disease (≥10g/L monoclonal gammapathy and/or ≥ 200 mg/24h proteinuria or
involved serum free light chain ≥ 100mg/L with abnormal FLC ratio < 0.26 or > 1.65)

- Patient in 1st relapse or refractory to 1st line therapy. Relapse is defined by
M-component increase of ≥25% from baseline, in serum and/or urine (the absolute
increase in serum must be ≥ 5 g/l - the absolute increase of BJ proteins in urine
must be ≥200 mg/24 h). (It is recommended to treat only symptomatic or rapidly
evolutive relapses)

- Life expectancy of at least 3 months

- ECOG performance status <= 2 at study entry

- Laboratory test results within these ranges:

- Absolute neutrophil count >= 1.5 x 109/L

- Platelet count >= 100 x 109/L

- Serum creatinine <= 250 umol/l

- AST (SGOT) and ALT (SGPT) <= 3 x ULN

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

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

- Using effective contraceptive methods during and for 6 months after study treatment
(for fertile men, women of childbearing potential).

- Provision of informed consent.

- A period of at least 15 days must be respected between the last treatment of myeloma
and the beginning of the study.

Exclusion Criteria:

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

- Any comorbidity which places the subject at unacceptable risk if he/she were to
participate in the study.

- Patients treated with high-dose therapy plus stem cell transplantation in 1st line

- Any prior use of bortezomib (Velcade) or bendamustine (Ribomustin)

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

- Use of any other experimental drug or therapy within 28 days prior to the start of
study treatment.

- Known hypersensitivity to the study drugs

- Positive HIV serology, positive hepatitis C serology, active infection hepatitis A,
active infection hepatitis B.

- Severe cardiovascular disorders within 12 months prior to the start of study
treatment (e.g. myocardial infarct, ischemic episodes, arrhythmias)

- Previous major surgery less than 30 days before start of treatment

- Active infection,

- Pregnant or lactating women.

Type of Study:


Study Design:

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

Outcome Measure:

To assess of the overall response rate (complete response (CR) + partial response (PR))

Outcome Time Frame:

After four 28-day consecutives cycles

Safety Issue:


Principal Investigator

Philippe RODON, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Unité Hématologie Biologique Institut Curie PARIS


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

Study ID:




Start Date:

January 2010

Completion Date:

June 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Elderly patients
  • first relapse
  • refractory to first line therapy
  • Bendamustine Velcade Dexamethasone Association
  • Multiple Myeloma
  • Neoplasms, Plasma Cell