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

This study is ongoing, but not recruiting participants.

Study NCT00477750 Information provided by Mayo Clinic

First Received on May 23, 2007. Last Updated on January 3, 2011 History of Changes

Results First Received: November 8, 2010

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Multiple Myeloma and Plasma Cell Neoplasm
Interventions:	Drug: lenalidomide Drug: melphalan Drug: prednisone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Melphalan + Prednisone + Lenalidomide	No text entered.

Participant Flow: Overall Study

	Melphalan + Prednisone + Lenalidomide
STARTED	26
COMPLETED	15
NOT COMPLETED	11
Currently Receiving Treatment	11

Baseline Characteristics

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Reporting Groups

	Description
Melphalan + Prednisone + Lenalidomide	No text entered.

Baseline Measures

	Melphalan + Prednisone + Lenalidomide
Number of Participants [units: participants]	26
Age [units: years] Median ( Full Range )	73.5 ( 64 to 87 )
Gender [units: participants]
Female	9
Male	17
Region of Enrollment [units: participants]
United States	26
Durie-Salmon Stage at Diagnoisis [units: 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 [units: participants]
Yes	20
No	6
Parameter of Hematologic Response - Serum Immunoglobulin Free Light Chain >= 10mg/dL [units: participants]
Yes	12
No	14
Parameter of Hematologic Response - Urine M-spike >= 200 mg/24 hours [units: participants]
Yes	6
No	20
Parameter of Hematologic Response - None (non-secretory myeloma, bone marrow only) [units: participants]
Yes	0
No	26

Outcome Measures

1. Primary:

Patients With Overall Confirmed Response [ Time Frame: Every cycle during treatment ]

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2. Secondary:

Time to Progression (TTP) [ Time Frame: registration to progressive disease (up to 3 years) ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Overall Survival (OS) [ Time Frame: registration to death (up to 3 years) ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Duration of Response (DOR) [ Time Frame: from first response to progression or death (up to 3 years) ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Patients With Grade 3 or Higher Adverse Events [ Time Frame: Every cycle during treatment ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dr. Vivek Roy
Organization: Mayo Clinic
e-mail: roy.vivek@mayo.edu

No publications provided

Responsible Party:	Vivek Roy, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier:	NCT00477750 History of Changes
Other Study ID Numbers:	CDR0000546642, P30CA015083, MC038A, 2387-04, RV-MM-PI-025
Study First Received:	May 23, 2007
Results First Received:	November 8, 2010
Last Updated:	January 3, 2011
Health Authority:	United States: Food and Drug Administration