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

NCT00478218 | Completed Phase 2 Results DMC

• 5 other identifiers: CDR0000546657P30CA015083MC058E06-002786RV-MM-PI-0116
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment

  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

  Duration of Treatment (up to 5 years)

Secondary Outcomes (3)

• Overall Survival (OS)

  up to 5 years

• Progression-free Survival (PFS)

  up to 5 years

• Duration of Response (DOR)

  up to 5 years

Study Arms (1)

Lenalidomide/Cyclophosphamide/Dexamethasone

EXPERIMENTAL

Drug: cyclophosphamide; Drug: dexamethasone; Drug: lenalidomide

Interventions

cyclophosphamide 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)

Also known as: Cytoxan, CTX, Neosar®

Lenalidomide/Cyclophosphamide/Dexamethasone

dexamethasone DRUG

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

Also known as: Decadron

Lenalidomide/Cyclophosphamide/Dexamethasone

lenalidomide DRUG

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

Also known as: Revlimid®

Lenalidomide/Cyclophosphamide/Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 21630308 RESULT

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Cyclophosphamide; Dexamethasone; Calcium Dobesilate; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Shaji Kumar
• Organization: Mayo Clinic

kumar.shaji@mayo.edu

Study Officials

• Shaji K. Kumar, MD

  Mayo Clinic

  STUDY CHAIR

• Craig B. Reeder, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2007
• First Posted: May 24, 2007
• Study Start: July 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: April 1, 2011
• Last Updated: August 31, 2011
• Results First Posted: July 27, 2011

Record last verified: 2011-08

Locations

US (2)