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Lenalidomide, Adriamycin, Dexamethasone (RAD) Versus Lenalidomide, Bortezomib, Dexamethasone (VRD) for Induction in Newly Diagnosed Multiple Myeloma Followed by Response-adapted Consolidation and Lenalidomide Maintenance - A Randomized Multicenter Phase III Trial by Deutsche Studiengruppe Multiples Myelom (DSMM XIV


Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Previously Untreated Symptomatic Multiple Myeloma

Thank you

Trial Information

Lenalidomide, Adriamycin, Dexamethasone (RAD) Versus Lenalidomide, Bortezomib, Dexamethasone (VRD) for Induction in Newly Diagnosed Multiple Myeloma Followed by Response-adapted Consolidation and Lenalidomide Maintenance - A Randomized Multicenter Phase III Trial by Deutsche Studiengruppe Multiples Myelom (DSMM XIV


Inclusion Criteria:



- Understand and voluntarily sign an informed consent form

- Patients willing and able to undergo autologous and allogeneic transplantation

- no previous systemic therapy for the treatment of multiple myeloma (dexamethasone at
a cumulative dose of 320 mg; plasmapheresis/dialysis without concomitant
chemotherapy, local irradiation of bone lesions; and surgical intervention is
accepted as pretreatment)

- Newly diagnosed multiple myeloma according to common diagnostic criteria including
presence of CRAB and measurable disease parameters

- Cardiac ejection fraction (LVEF) of at least 50%

- Corrected DLCO of at least 50% ; alternatively pO2 [art.] of at least 70mmHg

- Karnofsky performance status of greater or equal to 50%

- adequate bone marrow function

- adequate serum chemistry values

- Use of adequate contraception for female subjects with childbearing potential and
male subjects

- Bone marrow sample available for analysis of molecular cytogenetics

- Able to administer low molecular-weight heparin as a prophylactic anticoagulation
therapy for the first three months(applicable for subjects randomized to RAD) and
able to administer ASS 100 mg/d (applicable for subjects randomized to VRD)

Exclusion Criteria:

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

- Pregnant or lactating females

- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk

- History of myocardial infarction; NYHA Class III or IV heart failure, uncontrolled
angina, severe uncontrolled ventricular arrhythmias; concomitant pericarditis or
peri-/myocarditis

- Use of any other experimental drug or therapy within 28 days of baseline

- Greater or equal to Grade 2 peripheral neuropathy on clinical examination within 14
days before enrollment

- Known intolerance of boron

- Hypersensitivity to acyclovir or similar anti-viral drug

- Prior malignancy except adequately treated basal cell or squamous cell skin cancer,
in situ cervical, breast or prostate cancer

- HIV positive, active hepatitis B, C or D viral infection, known CMV
reactivation/active infection, EBV reactivation/active infection or treponema
pallidum infection

- Uncontrolled diabetes mellitus

- Non-secretory MM

- Clinically relevant active infection or serious co-morbid medical conditions

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary efficacy endpoint for the induction phase is the rate of patients with CR at first restaging

Outcome Time Frame:

within 8 days after end of last induction cycle ((Day 92(RAD); Day 71(VRD))

Safety Issue:

No

Principal Investigator

Stefan Knop, MD

Investigator Role:

Study Director

Investigator Affiliation:

Wuerzburg University Hospital

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

DSMM XIV

NCT ID:

NCT01685814

Start Date:

May 2012

Completion Date:

May 2020

Related Keywords:

  • Previously Untreated Symptomatic Multiple Myeloma
  • multiple myeloma
  • autologous stem cell transplant
  • allogeneic stem cell transplant
  • lenalidomide
  • bortezomib
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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