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Trial record 20 of 2514 for:    "Plasma Cell Neoplasm"

Melphalan, Prednisone, and Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00477750
Recruitment Status : Completed
First Posted : May 24, 2007
Results First Posted : December 13, 2010
Last Update Posted : April 18, 2017
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: lenalidomide
Drug: melphalan
Drug: prednisone
Enrollment 33
Recruitment Details  
Pre-assignment Details This was as Phase I/II trial. There were 7 patients recruited to the Phase I portion; no patients qualified for the Phase II portion. Twenty-six (26) patients were recruited for the Phase II portion. Results presented here are on the 26 Phase II patients.
Arm/Group Title Treatment (Lenalidomide, Melphalan, Prednisone)
Hide Arm/Group Description

Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression

Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression

Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression

Period Title: Overall Study
Started 26
Completed 15
Not Completed 11
Reason Not Completed
Currently Receiving Treatment             11
Arm/Group Title Treatment (Lenalidomide, Melphalan, Prednisone)
Hide Arm/Group Description

Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression

Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression

Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression

Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 26 participants
73.5
(64 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
9
  34.6%
Male
17
  65.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
Durie-Salmon Stage at Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
I - Low Cell Mass 1
II - Intermediate Cell Mass 11
III - High Cell Mass 11
unknown 3
Parameter of Hematologic Response - Serum M-spike >= 1g/dL  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
Yes 20
No 6
Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >= 10mg/dL  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
Yes 12
No 14
Parameter of Hematologic Response - Urine M-spike >= 200 mg/24 hours  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
Yes 6
No 20
Parameter of Hematologic Response - None (non-secretory myeloma, bone marrow only)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants
Yes 0
No 26
1.Primary Outcome
Title Patients With Overall Confirmed Response
Hide Description

Response that was confirmed on 2 consecutive evaluations. >

  • Complete Response (CR): Complete disappearance of M-protein from serum and urine on immunofixations, normalization of Free Light Chain (FLC) ratio and <=5% plasma cells in bone marrow >
  • Very Good Partial Response (VGPR): >=90% reduction in serum M-spike, Urine M-spike <100mg per 24 hours >
  • Partial Response (PR): >=50% reduction in serum M-spike, Urine M-spike >=90% reduction or < 200mg per 24 hours, or >=50% decrease in difference between involved and uninvolved FLC levels or 50% decrease in bone marrow plasma cells
Time Frame Every cycle during treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Lenalidomide, Melphalan, Prednisone)
Hide Arm/Group Description:

Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression > > Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression >

> Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression

Overall Number of Participants Analyzed 26
Measure Type: Number
Unit of Measure: participants
CR 3
VGPR 5
PR 10
2.Secondary Outcome
Title Time to Progression (TTP)
Hide Description TTP was defined as the time from registration to disease progression. Patients who died were considered to have disease progression at time of death unless documented evidence clearly indicates no progression has occurred
Time Frame registration to progressive disease (up to 3 years)
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from registration to death due to any cause. Patients who were alive were censored at date of last follow-up.
Time Frame registration to death (up to 3 years)
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Duration of Response (DOR)
Hide Description Duration of response was calculated from documentation of first response to date of progression in the subset of patients who responded. Patients without progression were censored at the date of last tumor evaluation.
Time Frame from first response to progression or death (up to 3 years)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Patients With Grade 3 or Higher Adverse Events
Hide Description Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0.
Time Frame Every cycle during treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Lenalidomide, Melphalan, Prednisone)
Hide Arm/Group Description

Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression

Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression

Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression

All-Cause Mortality
Treatment (Lenalidomide, Melphalan, Prednisone)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Lenalidomide, Melphalan, Prednisone)
Affected / at Risk (%) # Events
Total   7/26 (26.92%)    
Gastrointestinal disorders   
Diarrhea  1  1/26 (3.85%)  1
Infections and infestations   
Sepsis  1  1/26 (3.85%)  1
Skin infection  1  1/26 (3.85%)  1
Investigations   
Creatinine increased  1  1/26 (3.85%)  1
Leukocyte count decreased  1  1/26 (3.85%)  1
Neutrophil count decreased  1  2/26 (7.69%)  2
Platelet count decreased  1  2/26 (7.69%)  2
Metabolism and nutrition disorders   
Dehydration  1  1/26 (3.85%)  1
Skin and subcutaneous tissue disorders   
Rash desquamating  1  1/26 (3.85%)  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%
Treatment (Lenalidomide, Melphalan, Prednisone)
Affected / at Risk (%) # Events
Total   26/26 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin decreased  1  24/26 (92.31%)  103
Lymphatic disorder  1  1/26 (3.85%)  1
Cardiac disorders   
Myocardial ischemia  1  1/26 (3.85%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/26 (3.85%)  1
Constipation  1  1/26 (3.85%)  1
Dyspepsia  1  4/26 (15.38%)  5
Ear, nose and throat examination abnormal  1  2/26 (7.69%)  2
Nausea  1  8/26 (30.77%)  12
General disorders   
Edema limbs  1  11/26 (42.31%)  27
Fatigue  1  21/26 (80.77%)  63
Fever  1  1/26 (3.85%)  1
Pain  1  2/26 (7.69%)  5
Immune system disorders   
Hypersensitivity  1  1/26 (3.85%)  1
Infections and infestations   
Colitis, infectious (e.g., Clostridium difficile)  1  1/26 (3.85%)  1
Pneumonia  1  1/26 (3.85%)  1
Skin infection  1  2/26 (7.69%)  5
Upper respiratory infection  1  1/26 (3.85%)  1
Urinary tract infection  1  1/26 (3.85%)  1
Investigations   
Alkaline phosphatase increased  1  1/26 (3.85%)  1
Aspartate aminotransferase increased  1  1/26 (3.85%)  1
Blood bilirubin increased  1  1/26 (3.85%)  1
Leukocyte count decreased  1  6/26 (23.08%)  13
Lymphocyte count decreased  1  1/26 (3.85%)  1
Neutrophil count decreased  1  18/26 (69.23%)  58
Platelet count decreased  1  18/26 (69.23%)  70
Metabolism and nutrition disorders   
Blood glucose increased  1  15/26 (57.69%)  32
Serum albumin decreased  1  1/26 (3.85%)  1
Serum calcium decreased  1  1/26 (3.85%)  1
Serum glucose decreased  1  1/26 (3.85%)  1
Serum potassium decreased  1  1/26 (3.85%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness  1  9/26 (34.62%)  17
Pain in extremity  1  1/26 (3.85%)  1
Nervous system disorders   
Headache  1  1/26 (3.85%)  1
Peripheral sensory neuropathy  1  5/26 (19.23%)  8
Syncope  1  2/26 (7.69%)  2
Psychiatric disorders   
Confusion  1  1/26 (3.85%)  1
Skin and subcutaneous tissue disorders   
Rash desquamating  1  6/26 (23.08%)  14
Vascular disorders   
Hypotension  1  1/26 (3.85%)  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. Vivek Roy
Organization: Mayo Clinic
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00477750     History of Changes
Other Study ID Numbers: CDR0000546642
P30CA015083 ( U.S. NIH Grant/Contract )
MC038A ( Other Identifier: Mayo Clinic Cancer Center )
2387-04 ( Other Identifier: Mayo Clinic IRB )
RV-MM-PI-025 ( Other Identifier: Celgene protocol )
First Submitted: May 23, 2007
First Posted: May 24, 2007
Results First Submitted: November 8, 2010
Results First Posted: December 13, 2010
Last Update Posted: April 18, 2017