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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| MC058E | Other Identifier | Mayo Clinic Cancer Center | |
| 06-002786 | Other Identifier | Mayo Clinic IRB | |
| RV-MM-PI-0116 | Other Identifier | Celgene Protocol |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
After completion of study treatment, patients are followed every 6 months for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide/Cyclophosphamide/Dexamethasone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| Duration of Treatment (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | 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. | up to 5 years |
| Progression-free Survival (PFS) |
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
Measurable or evaluable disease, defined by ≥ 1 of the following criteria:
No monoclonal gammopathy of undetermined significance or smoldering myeloma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Shaji K. Kumar, MD | Mayo Clinic | Study Chair |
| Craig B. Reeder, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | United States | ||
| Mayo Clinic Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21630308 | Result | 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. |
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Fifty-three (53) participants were recruited between July 2006 and August 2008 at Mayo Clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | LCD (Cyclophosphamide 300 mg/m^2) | Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22 |
| FG001 | LCD (Cyclophosphamide 300 mg) | Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LCD (Cyclophosphamide 300 mg/m^2) | Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22 |
| BG001 | LCD (Cyclophosphamide 300 mg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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
| Posted | Number | participants | Duration of Treatment (up to 5 years) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LCD (Cyclophosphamide 300 mg/m^2) | Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shaji Kumar | Mayo Clinic | kumar.shaji@mayo.edu |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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|
| dexamethasone | Drug | 40 mg administrated by PO (with food)on Days 1, 8, 15 & 22 |
|
|
| lenalidomide | Drug | 25 mg administrated by PO (with food)on Days 1-21 |
|
|
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:>
|
| up to 5 years |
| Duration of Response (DOR) | 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. | up to 5 years |
| Rochester |
| Minnesota |
| 55905 |
| United States |
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Durie Salmon Stage | Number | paricipants |
|
| Parameter of Hematologic Response - Serum M-spike >= 1 g/dL | Number | participants |
|
| Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >= 10 mg/dL | Number | participants |
|
| Parameter of Hematologic Response - Urine M-Spike >= 200 mg/24 hours | Number | participants |
|
| Parameter of Hematologic Response - Bone Marrow Plasma Cells > 30% | Number | participants |
|
| OG001 | LCD (Cyclophosphamide 300 mg) | Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22 |
|
|
| Secondary | Overall Survival (OS) | 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. | Posted | Median | 95% Confidence Interval | months | up to 5 years |
|
|
|
| Secondary | Progression-free Survival (PFS) | 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:>
| Posted | Median | 95% Confidence Interval | months | up to 5 years |
|
|
|
| Secondary | Duration of Response (DOR) | 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. | Participants who achieved a partial response(PR) or better were evaluable for this analysis. | Posted | Median | 95% Confidence Interval | months | up to 5 years |
|
|
|
| 13 |
| 34 |
| 34 |
| 34 |
| EG001 | LCD (Cyclophosphamide 300 mg) | Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22 | 2 | 19 | 19 | 19 |
| Atrial fibrillation | Cardiac disorders | MedDRA 6 | Systematic Assessment |
|
| Lower gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Death NOS | General disorders | MedDRA 6 | Systematic Assessment |
|
| Lung (pneumonia) infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Skin (cellulites) infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Creatinine | Investigations | MedDRA 6 | Systematic Assessment |
|
| Leukopenia | Investigations | MedDRA 6 | Systematic Assessment |
|
| Neutropenia | Investigations | MedDRA 6 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Ischemia-Cerebral | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 6 | Systematic Assessment |
|
| Cardiovascular | Cardiac disorders | MedDRA 6 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 6 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 6 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Diarrhea-No Colostom | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Oral cavity Mucositis/stomatitis (functional/symptomatic) | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Pain-Abdominal | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
|
| Edema: Limb | General disorders | MedDRA 6 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
|
| Fever-No ANC | General disorders | MedDRA 6 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Skin (cellulites) infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
|
| Creatinine | Investigations | MedDRA 6 | Systematic Assessment |
|
| Leukopenia | Investigations | MedDRA 6 | Systematic Assessment |
|
| Lymphopenia | Investigations | MedDRA 6 | Systematic Assessment |
|
| Neutropenia | Investigations | MedDRA 6 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Extremity-lower weakness | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Extremity-upper weakness | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Muscle Weakness | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Secondary Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 6 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Syncope Vasovagal | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 6 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Euphoria | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
|
| Cystitis | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
|
| Impotence | Reproductive system and breast disorders | MedDRA 6 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Rash/Desquamation | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
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| D002318 |
| Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |