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A Randomized, Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib, and Dexamethasone (RVD) to High-Dose Treatment With Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients Up to 65 Years of Age


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

Thank you

Trial Information

A Randomized, Phase III Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib, and Dexamethasone (RVD) to High-Dose Treatment With Peripheral Stem Cell Transplant in the Initial Management of Myeloma in Patients Up to 65 Years of Age


After screening procedures determine if a patient is eligible for this research study, the
patient will be randomized into one of the study groups: lenalidomide, bortezomib and
dexamethasone without autologous stem cell transplantation, followed by lenalidomide
maintenance (Arm A) or lenalidomide, bortezomib and dexamethasone with autologous stem cell
transplantation, followed by lenalidomide maintenance (Arm B). There is an equal chance of
being placed in either group.

All participants will receive one cycle of lenalidomide, bortezomib and dexamethasone
treatment before being randomized to Arm A or Arm B.

Participants in Arm A will receive two additional cycles of lenalidomide, bortezomib and
dexamethasone prior to stem cell collection. If randomized to Arm A, the subject will
undergo stem cell collection, followed by five cycles of lenalidomide, bortezomib and
dexamethasone. This will be followed by lenalidomide maintenance treatment until disease
progression.

Participants in Arm B will receive two additional cycles of lenalidomide, bortezomib and
dexamethasone prior to stem cell collection. If randomized to Arm B, the subject will
undergo stem cell collection and autologous stem cell transplantation, followed by two
cycles of lenalidomide, bortezomib and dexamethasone. This will be followed by lenalidomide
maintenance treatment until disease progression.


Inclusion Criteria:



- Diagnosis of Multiple Myeloma, according to the International Myeloma Foundation 2003
Diagnostic Criteria

- Documented symptomatic myeloma, with organ damage related to myeloma with laboratory
assessments performed within 21 days of registration

- Myeloma that is measurable by either serum or urine evaluation of the monoclonal
component or by assay of serum free light chains.

- ECOG performance status
- Negative HIV blood test

- Voluntary written informed consent

Exclusion Criteria:

- Pregnant or lactating female

- Prior systemic therapy for MM (localized radiotherapy allowed if >/= 2 weeks before
study entry, corticosteroids allowed if dose over 2 weeks)

- Primary amyloidosis (AL) or myeloma complicated by amylosis

- Receiving any other investigational agents

- Known brain metastases

- Poor tolerability or allergy to any of the study drugs or compounds of similar
composition

- Platelet count <50,000/mm3, within 21 days of registration

- ANC <1,000 cells/mm3, within 21 days of registration

- Hemoglobin <8 g/dL, within 21 days of registration

- Hepatic impairment (>/= 1.5 x institutional ULN or AST (SGOT), ALT (SGPT), or
alkaline phosphatase >2 x ULN). Patients with benign hyperbilirubinemia are eligible.

- Renal insufficiency (serum creatinine >2.0 mg/dl or creatinine clearance <50 ml/min,
within 21 days of registration)

- Respiratory compromise (DLCO < 50%)

- Clinical signs of heart or coronary failure or LVEF < 40%. Myocardial infarction
within 6 months prior to enrollment, NYHA Class III or IV heart failure, uncontrolled
angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
of acute ischemia or active conductive system abnormalities

- Intercurrent illness including, but not limited to ongoing or active severe
infection, known infection with hepatitis B or C virus, poorly controlled diabetes,
severe uncontrolled psychiatric disorder or psychiatric illness/social situations
that would limit compliance with study requirements

- Previous history of another malignant condition except for basal cell carcinoma and
stage I cervical cancer

- Inability to comply with an anti-thrombotic treatment regimen

- Peripheral neuropathy >/= Grade 2

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Primary Outcome

Outcome Description:

To compare progression-free survival (PFS) between Arm A and Arm B.

Outcome Time Frame:

Up to 6 years or until progression

Safety Issue:

No

Principal Investigator

Paul G. Richardson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

10-106

NCT ID:

NCT01208662

Start Date:

September 2010

Completion Date:

September 2018

Related Keywords:

  • Multiple Myeloma
  • Lenalidomide
  • Bortezomib
  • Dexamethasone
  • Stem Cell Transplant
  • Myeloma
  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Wake Forest University Winston-Salem, North Carolina  27103
University of Michigan Ann Arbor, Michigan  48109-0624
Memorial Sloan Kettering Cancer Center New York, New York  10021
MD Anderson Cancer Center Houston, Texas  77030-4096
Roswell Park Cancer Institute Buffalo, New York  14263
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Stanford University Stanford, California  94305
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Mount Sinai Medical Center New York, New York  10029
Massachusetts General Hospital Boston, Massachusetts  02114-2617
University of California, San Francisco San Francisco, California  94143
Duke University Durham, North Carolina  27710
Emory University Atlanta, Georgia  30322
University of Chicago Chicago, Illinois  60637
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina  
Cape Cod Healthcare Hyannis, Massachusetts  02601