Know Cancer

forgot password

An Open, Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

An Open, Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Bendamustine, Lenalidomide (Revlimid®) and Dexamethasone (BRd) as 2nd-line Therapy for Patients With Relapsed or Refractory Multiple Myeloma

Assessments for efficacy / response evaluation:

- M-protein quantitation in serum and 24 h urine collection samples by serum- and urine
protein electrophoresis

- Quantitation of immunoglobulin levels by nephelometry

- Serum and urine immunofixation

- Free light chain concentrations and ratio in the serum

- Plasma cell percentage in the bone marrow by conventional cytology and biopsy with

- Radiologic assessments of the skeleton

Response criteria: Response will be assessed according to IMWG criteria

Inclusion Criteria:

- Written informed consent to be obtained before any study specific procedure

- Patients with first relapsed or refractory multiple myeloma (including patients with
relapse after high dose chemotherapy followed by autologous stem cell
transplantation) who have received no more than one prior line of anti-myeloma

- Treatment with a lenalidomide/ dexamethasone-based 2nd-line regimen is indicated and

- Measurable disease as defined by at least one of the following 3 measurements

- serum monoclonal protein level ≥ 1 g/dl (≥ 10 g/l) or

- urine M-protein level ≥ 200 mg/24hours or

- serum FLC assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) provided serum FLC
ratio is abnormal

- ECOG performance status 0, 1, or 2

- Age ≥ 18 years

- All previous cancer therapy (except corticosteroid therapy), including radiation,
cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to
treatment in this study.

- No prior treatment with a bendamustine- or lenalidomide-containing regimen allowed

- Adequate hematological values:

- absolute neutrophil count ≥ 1.5 x 109/L

- platelets ≥ 100 x 109/L

- hemoglobin > 80 g/L, unless considered to be caused by the underlying
hematologic malignancy, based on the investigator's clinical judgement

- Adequate hepatic function:

- total bilirubin < 1.2 mg/dL

- AST (SGOT) ≤ 2.5 x ULN

- Adequate renal function:

o calculated creatinine clearance > 50 ml/min, according to the formula of

- Disease free of prior malignancies for > 5 years with the exception of:

- currently treated basal cell, squamous cell carcinoma of the skin, or

- carcinoma "in situ" of the cervix or breast

Exclusion Criteria:

- Pregnant or breast feeding females

- Any prior use of lenalidomide or bendamustine

- Patients who are unable or unwillingly to undergo antithrombotic therapy

- Any serious underlying medical condition (at the judgment of the investigator) which
impairs the ability of the patient to participate in the trial (e.g. active
autoimmune disease, uncontrolled diabetes, ongoing or active infection, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric

- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she would participate in the study or any
condition significantly confounding the ability to interpret data from the study,
based on the local investigator's judgement

- Severe cardiovascular disease, including myocardial infarction within 6 months before
study entry, New York Heart Association Class III or IV heart failure, uncontrolled
angina or severe uncontrolled ventricular arrhythmias (≥ Lown 3)

- Use of any other experimental drug or therapy/ treatment in a clinical trial within
30 days prior to trial entry

- Known hypersensitivity to study drug(s) or hypersensitivity to any other component of
the study drugs

- Any concurrent antineoplastic therapy with chemotherapeutic agents or biologic agents
or radiation therapy

- Any major surgical procedure within 30 days prior to study therapy

- Known chronic hepatitis B or C, known HIV infection

- Jaundice or any other severe damage of the liver parenchyma

- Any contraindication for the treatment with bendamustine, lenalidomide, dexamethasone
and / or pegfilgrastim in accordance with the appropriate SmPCs

- Any other concomitant drugs contraindicated for use with the study drugs according to
the national health authorities

Type of Study:


Study Design:

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

Outcome Measure:

Efficacy (combined CR-/VGPR-rate) achieved during the induction treatment phase or within four weeks after the last administration of six induction cycles of the BRd regimen

Outcome Time Frame:

Every 4 weeks up to 7 months

Safety Issue:


Principal Investigator

Ulrich Mey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kantonsspital Graubünden


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

March 2012

Completion Date:

March 2015

Related Keywords:

  • Multiple Myeloma
  • Relapsed / refractory multiple myeloma
  • 2nd line treatment
  • Multiple Myeloma
  • Neoplasms, Plasma Cell