Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00478218
First received: May 23, 2007
Last updated: August 29, 2011
Last verified: August 2011

May 23, 2007
August 29, 2011
July 2006
September 2008   (final data collection date for primary outcome measure)
Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment [ Time Frame: Duration of Treatment (up to 5 years) ] [ Designated as safety issue: No ]

Response that was confirmed on 2 consecutive evaluations during treatment

  • Complete Response(CR): Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)
  • Very Good Partial Response(VGPR): >=90% reduction in serum M-component; Urine M-Component <100 mg per 24 hours; <=5% plasma cells in BM
  • Partial Response PR): >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels
Confirmed response (complete, partial, or very good partial response)
Complete list of historical versions of study NCT00478218 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    OS was defined as the time from registration to death of any cause. Participants were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.
  • Progression-free Survival (PFS) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

    PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.

    >

    Progression was defined as any one or more of the following:

    >

    An increase of 25% from lowest confirmed response in:

    • Serum M-component (absolute increase >= 0.5g/dl)
    • Urine M-component (absolute increase >= 200mg/24hour
    • Difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl
    • Bone marrow plasma cell percentage (absolute increase of >=10%)
  • Duration of Response (DOR) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. The median DOR with 95%CI was estimated using the Kaplan Meier method.
  • Overall survival
  • Progression-free survival
  • Duration of response
Not Provided
Not Provided
 
Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
A Phase II Trial of Revlimid, Cyclophosphamide, and Dexamethasone in Patients With > Newly Diagnosed Active Multiple Myeloma

RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with cyclophosphamide and dexamethasone may kill more cancer cells.> PURPOSE: This phase II trial is studying how well giving lenalidomide together with cyclophosphamide and dexamethasone works in treating patients with newly diagnosed multiple myeloma.

OBJECTIVES:

Primary

* Assess the response rate in patients with newly diagnosed active multiple myeloma treated with lenalidomide, cyclophosphamide, and dexamethasone.

Secondary

  • Assess the toxicity of this regimen in these patients.
  • Determine the time to progression in patients treated with this regimen. OUTLINE: Patients receive oral lenalidomide on days 1-21, oral cyclophosphamide on days 1, 8, and 15, and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma and Plasma Cell Neoplasm
  • Drug: cyclophosphamide
    300 mg/m2 administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles) OR 300 mg administrated by PO (with food)on Days 1, 8, 15 (up to 12 cycles)
    Other Name: Cytoxan, CTX, Neosar®
  • Drug: dexamethasone
    40 mg administrated by PO (with food)on Days 1, 8, 15 & 22
    Other Name: Decadron
  • Drug: lenalidomide
    25 mg administrated by PO (with food)on Days 1-21
    Other Name: Revlimid®
Experimental: Lenalidomide/Cyclophosphamide/Dexamethasone
Interventions:
  • Drug: cyclophosphamide
  • Drug: dexamethasone
  • Drug: lenalidomide
Kumar SK, Lacy MQ, Hayman SR, Stewart K, Buadi FK, Allred J, Laumann K, Greipp PR, Lust JA, Gertz MA, Zeldenrust SR, Bergsagel PL, Reeder CB, Witzig TE, Fonseca R, Russell SJ, Mikhael JR, Dingli D, Rajkumar SV, Dispenzieri A. Lenalidomide, cyclophosphamide and dexamethasone (CRd) for newly diagnosed multiple myeloma: results from a phase 2 trial. Am J Hematol. 2011 Aug;86(8):640-5. doi: 10.1002/ajh.22053. Epub 2011 May 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
April 2011
September 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of multiple myeloma

    • Newly diagnosed disease
    • Symptomatic disease
  • Measurable or evaluable disease, defined by ≥ 1 of the following criteria:

    • Serum monoclonal protein ≥ 1.0 g by protein electrophoresis
    • Monoclonal protein > 200 mg by 24-hour urine electrophoresis
    • Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
    • Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)
    • Measurable soft tissue plasmacytoma not previously irradiated
  • No monoclonal gammopathy of undetermined significance or smoldering myeloma

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if secondary to pain)
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 75,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Creatinine ≤ 2.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for 1 month before, during, and for 4 weeks after completion of study therapy
  • No uncontrolled infection
  • No other active malignancy
  • No other malignancies within the past 5 years except for currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
  • No NYHA class III-IV congestive heart failure
  • No untreated active deep vein thrombosis

PRIOR CONCURRENT THERAPY:

  • At least 3 weeks since prior radiotherapy for solitary plasmacytoma
  • Prior clarithromycin, therapeutic dehydroepiandrosterone (DHEA), anakinra, pamidronate disodium, or zoledronic acid allowed
  • No prior cytotoxic chemotherapy
  • No prior corticosteroids (except for treatment of a nonmalignant disorder)
  • Concurrent corticosteroids (prednisone ≤ 20 mg/per day) allowed
  • No concurrent radiotherapy except palliative radiotherapy for a single painful bone lesion or fracture
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00478218
CDR0000546657, P30CA015083, MC058E, 06-002786, RV-MM-PI-0116
Yes
Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Study Chair: Shaji K. Kumar, MD Mayo Clinic
Principal Investigator: Craig B. Reeder, MD Mayo Clinic
Mayo Clinic
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP