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Trial record 19 of 2516 for:    "Plasma Cell Neoplasm"

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

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ClinicalTrials.gov Identifier: NCT00478218
Recruitment Status : Completed
First Posted : May 24, 2007
Results First Posted : July 27, 2011
Last Update Posted : August 31, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma and Plasma Cell Neoplasm
Interventions Drug: cyclophosphamide
Drug: dexamethasone
Drug: lenalidomide
Enrollment 53
Recruitment Details Fifty-three (53) participants were recruited between July 2006 and August 2008 at Mayo Clinic.
Pre-assignment Details  
Arm/Group Title LCD (Cyclophosphamide 300 mg/m^2) LCD (Cyclophosphamide 300 mg)
Hide Arm/Group Description 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 Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
Period Title: Overall Study
Started 34 19
Completed 34 19
Not Completed 0 0
Arm/Group Title LCD (Cyclophosphamide 300 mg/m^2) LCD (Cyclophosphamide 300 mg) Total
Hide Arm/Group Description 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 Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22 Total of all reporting groups
Overall Number of Baseline Participants 34 19 53
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants 19 participants 53 participants
63.5
(44 to 79)
65
(37 to 82)
64
(37 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 19 participants 53 participants
Female
17
  50.0%
9
  47.4%
26
  49.1%
Male
17
  50.0%
10
  52.6%
27
  50.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 19 participants 53 participants
34 19 53
Durie Salmon Stage  
Measure Type: Number
Unit of measure:  Paricipants
Number Analyzed 34 participants 19 participants 53 participants
Stage IA - Low Cell Mass 3 1 4
Stage IIA - Intermediate Cell Mass 7 11 18
Stage IIIA/B - High Cell Mass 24 7 31
Parameter of Hematologic Response - Serum M-spike >= 1 g/dL  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 19 participants 53 participants
Yes 25 14 39
No 9 5 14
Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >= 10 mg/dL  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 19 participants 53 participants
Yes 21 14 35
No 13 5 18
Parameter of Hematologic Response - Urine M-Spike >= 200 mg/24 hours  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 19 participants 53 participants
Yes 11 5 16
No 23 14 37
Parameter of Hematologic Response - Bone Marrow Plasma Cells > 30%  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34 participants 19 participants 53 participants
Yes 17 14 31
No 17 5 22
1.Primary Outcome
Title Number of Participants Who Achieved a Confirmed Response (CR), Very Good Partial Response (VGPR) or Partial Response (PR) During Treatment
Hide Description

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
Time Frame Duration of Treatment (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LCD (Cyclophosphamide 300 mg/m^2) LCD (Cyclophosphamide 300 mg)
Hide Arm/Group Description:
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
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
Overall Number of Participants Analyzed 34 19
Measure Type: Number
Unit of Measure: participants
28 16
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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.
Time Frame up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LCD (Cyclophosphamide 300 mg/m^2) LCD (Cyclophosphamide 300 mg)
Hide Arm/Group Description:
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
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
Overall Number of Participants Analyzed 34 19
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
[1]
Median OS for group 1 has not been attained.
[2]
Median OS for group 2 has not been attained.
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description

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%)
Time Frame up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LCD (Cyclophosphamide 300 mg/m^2) LCD (Cyclophosphamide 300 mg)
Hide Arm/Group Description:
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
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
Overall Number of Participants Analyzed 34 19
Median (95% Confidence Interval)
Unit of Measure: months
27
(14 to 32.6)
NA [1] 
(NA to NA)
[1]
The median PFS for group 2 has not been attained
4.Secondary Outcome
Title Duration of Response (DOR)
Hide Description 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.
Time Frame up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who achieved a partial response(PR) or better were evaluable for this analysis.
Arm/Group Title LCD (Cyclophosphamide 300 mg/m^2) LCD (Cyclophosphamide 300 mg)
Hide Arm/Group Description:
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
Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
Overall Number of Participants Analyzed 26 16
Median (95% Confidence Interval)
Unit of Measure: months
26.1
(17.5 to 31.7)
NA [1] 
(NA to NA)
[1]
Median DOR for group 2 has not been attained.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LCD (Cyclophosphamide 300 mg/m^2) LCD (Cyclophosphamide 300 mg)
Hide Arm/Group Description 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 Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
All-Cause Mortality
LCD (Cyclophosphamide 300 mg/m^2) LCD (Cyclophosphamide 300 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LCD (Cyclophosphamide 300 mg/m^2) LCD (Cyclophosphamide 300 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/34 (38.24%)      2/19 (10.53%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  1/34 (2.94%)  1 1/19 (5.26%)  1
Cardiac disorders     
Atrial fibrillation  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Gastrointestinal disorders     
Lower gastrointestinal hemorrhage  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Nausea  1  1/34 (2.94%)  1 0/19 (0.00%)  0
General disorders     
Death NOS  1  0/34 (0.00%)  0 1/19 (5.26%)  1
Infections and infestations     
Lung (pneumonia) infection  1  0/34 (0.00%)  0 1/19 (5.26%)  1
Pneumonia  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Sepsis  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Skin (cellulites) infection  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Investigations     
Creatinine  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Leukopenia  1  2/34 (5.88%)  2 0/19 (0.00%)  0
Neutropenia  1  5/34 (14.71%)  5 0/19 (0.00%)  0
Platelet count decreased  1  1/34 (2.94%)  2 0/19 (0.00%)  0
Metabolism and nutrition disorders     
Hypocalcemia  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Hypokalemia  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  2/34 (5.88%)  2 1/19 (5.26%)  1
Pain in extremity  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Nervous system disorders     
Ischemia-Cerebral  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Psychiatric disorders     
Confusion  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Depression  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Renal and urinary disorders     
Renal Failure  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  0/34 (0.00%)  0 1/19 (5.26%)  1
Vascular disorders     
Hypotension  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Thrombosis  1  3/34 (8.82%)  3 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
LCD (Cyclophosphamide 300 mg/m^2) LCD (Cyclophosphamide 300 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/34 (100.00%)      19/19 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  14/34 (41.18%)  50 10/19 (52.63%)  37
Cardiac disorders     
Atrial fibrillation  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Cardiovascular  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Sinus bradycardia  1  1/34 (2.94%)  1 1/19 (5.26%)  1
Endocrine disorders     
Hypothyroidism  1  2/34 (5.88%)  3 1/19 (5.26%)  1
Eye disorders     
Cataract  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  2/34 (5.88%)  2 2/19 (10.53%)  3
Diarrhea-No Colostom  1  7/34 (20.59%)  17 3/19 (15.79%)  6
Dyspepsia  1  1/34 (2.94%)  1 1/19 (5.26%)  1
Nausea  1  3/34 (8.82%)  5 0/19 (0.00%)  0
Oral cavity Mucositis/stomatitis (functional/symptomatic)  1  0/34 (0.00%)  0 1/19 (5.26%)  1
Pain-Abdominal  1  2/34 (5.88%)  2 0/19 (0.00%)  0
Vomiting  1  3/34 (8.82%)  3 0/19 (0.00%)  0
General disorders     
Edema: Limb  1  3/34 (8.82%)  5 1/19 (5.26%)  1
Fatigue  1  31/34 (91.18%)  239 18/19 (94.74%)  174
Fever-No ANC  1  0/34 (0.00%)  0 2/19 (10.53%)  2
Infections and infestations     
Pneumonia  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Respiratory tract infection  1  1/34 (2.94%)  1 1/19 (5.26%)  1
Skin (cellulites) infection  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Investigations     
Creatinine  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Leukopenia  1  21/34 (61.76%)  96 14/19 (73.68%)  67
Lymphopenia  1  2/34 (5.88%)  24 4/19 (21.05%)  24
Neutropenia  1  31/34 (91.18%)  288 16/19 (84.21%)  163
Platelet count decreased  1  19/34 (55.88%)  70 12/19 (63.16%)  86
Metabolism and nutrition disorders     
Anorexia  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Dehydration  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Hyperglycemia  1  0/34 (0.00%)  0 5/19 (26.32%)  13
Hyperkalemia  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Hypocalcemia  1  0/34 (0.00%)  0 1/19 (5.26%)  1
Hypoglycemia  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/34 (2.94%)  1 2/19 (10.53%)  2
Back pain  1  3/34 (8.82%)  8 1/19 (5.26%)  2
Bone pain  1  3/34 (8.82%)  7 0/19 (0.00%)  0
Extremity-lower weakness  1  1/34 (2.94%)  1 3/19 (15.79%)  5
Extremity-upper weakness  1  1/34 (2.94%)  1 1/19 (5.26%)  1
Muscle Weakness  1  4/34 (11.76%)  4 3/19 (15.79%)  4
Musculoskeletal  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Myalgia  1  2/34 (5.88%)  2 1/19 (5.26%)  4
Neck pain  1  1/34 (2.94%)  2 0/19 (0.00%)  0
Pain in extremity  1  2/34 (5.88%)  3 3/19 (15.79%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Secondary Malignancy  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Nervous system disorders     
Peripheral motor neuropathy  1  0/34 (0.00%)  0 1/19 (5.26%)  1
Peripheral sensory neuropathy  1  17/34 (50.00%)  61 14/19 (73.68%)  108
Syncope  1  0/34 (0.00%)  0 1/19 (5.26%)  1
Syncope Vasovagal  1  0/34 (0.00%)  0 1/19 (5.26%)  1
Tremor  1  1/34 (2.94%)  1 2/19 (10.53%)  3
Psychiatric disorders     
Agitation  1  4/34 (11.76%)  8 0/19 (0.00%)  0
Anxiety  1  5/34 (14.71%)  8 1/19 (5.26%)  1
Confusion  1  2/34 (5.88%)  3 0/19 (0.00%)  0
Depression  1  4/34 (11.76%)  5 2/19 (10.53%)  2
Euphoria  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Insomnia  1  3/34 (8.82%)  12 4/19 (21.05%)  6
Renal and urinary disorders     
Cystitis  1  6/34 (17.65%)  8 2/19 (10.53%)  2
Renal Failure  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Reproductive system and breast disorders     
Impotence  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Dyspnea  1  2/34 (5.88%)  2 0/19 (0.00%)  0
Skin and subcutaneous tissue disorders     
Petechiae  1  0/34 (0.00%)  0 1/19 (5.26%)  1
Rash/Desquamation  1  3/34 (8.82%)  5 4/19 (21.05%)  8
Skin Irritation  1  0/34 (0.00%)  0 1/19 (5.26%)  2
Vascular disorders     
Phlebitis  1  1/34 (2.94%)  1 0/19 (0.00%)  0
Thrombosis  1  4/34 (11.76%)  5 1/19 (5.26%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Shaji Kumar
Organization: Mayo Clinic
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00478218     History of Changes
Other Study ID Numbers: CDR0000546657
P30CA015083 ( U.S. NIH Grant/Contract )
MC058E ( Other Identifier: Mayo Clinic Cancer Center )
06-002786 ( Other Identifier: Mayo Clinic IRB )
RV-MM-PI-0116 ( Other Identifier: Celgene Protocol )
First Submitted: May 23, 2007
First Posted: May 24, 2007
Results First Submitted: June 30, 2011
Results First Posted: July 27, 2011
Last Update Posted: August 31, 2011