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

NCT ID: NCT00478218

Last Updated: 2011-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2011-04-30

Brief Summary

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.

Detailed Description

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenalidomide/Cyclophosphamide/Dexamethasone

Group Type: EXPERIMENTAL

cyclophosphamide

Intervention Type: DRUG

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)

dexamethasone

Intervention Type: DRUG

40 mg administrated by PO (with food)on Days 1, 8, 15 \& 22

lenalidomide

Intervention Type: DRUG

25 mg administrated by PO (with food)on Days 1-21

Interventions

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)

Intervention Type: DRUG

dexamethasone

40 mg administrated by PO (with food)on Days 1, 8, 15 \& 22

Intervention Type: DRUG

lenalidomide

25 mg administrated by PO (with food)on Days 1-21

Intervention Type: DRUG

Other Intervention Names

Cytoxan, CTX, Neosar®; Decadron; Revlimid®

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shaji K. Kumar, MD

Role: STUDY_CHAIR

Mayo Clinic

Craig B. Reeder, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21630308 (View on PubMed)

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MC058E

Identifier Type: OTHER

Identifier Source: secondary_id

06-002786

Identifier Type: OTHER

Identifier Source: secondary_id

RV-MM-PI-0116

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000546657

Identifier Type: -

Identifier Source: org_study_id