Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00033332

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not yet known whether dexamethasone is more effective with or without thalidomide in treating multiple myeloma.

PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: dexamethasone Drug: pamidronate disodium Drug: thalidomide Drug: zoledronic acid	Phase 3

Detailed Description

OBJECTIVES:

Compare the response rate of patients with newly diagnosed multiple myeloma treated with dexamethasone with or without thalidomide.
Compare the toxicity of these regimens in these patients.
Assess the effect of thalidomide on bone marrow microvessel density and angiogenesis grade and on the expression of vascular endothelial growth factor and basic fibroblast growth factor in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral thalidomide once daily on days 1-28 and oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients also receive either pamidronate IV over 2-4 hours or zoledronate IV over 15 minutes on day 1 for bone strengthening.
Arm II: Patients receive dexamethasone and pamidronate or zoledronate as in arm I.

Treatment in both arms repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses after the fourth course at the physician's discretion.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 194 patients (97 per treatment arm) will be accrued for this study.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Mar 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Newly diagnosed symptomatic multiple myeloma confirmed by the following:
Bone marrow plasmacytosis with at least 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytosis
Monoclonal protein (M protein) at least 1.0 g/dL on serum protein electrophoresis or at least 200 mg of monoclonal light chain on a 24-hour urine protein electrophoresis
No smoldering myeloma or monoclonal gammopathy of undetermined significance

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count greater than 1,000/mm^3
Platelet count greater than 50,000/mm^3
Hemoglobin greater than 7 g/dL

Hepatic:

Bilirubin no greater than 1.5 mg/dL
ALT and AST no greater than 2.5 times upper limit of normal

Renal:

Creatinine less than 3 mg/dL

Cardiovascular:

No prior or concurrent deep venous thrombosis

Other:

Prior malignancy allowed provided the following criteria are met:
Received prior treatment with curative intent
Free of disease for the time period appropriate for cure of the specific cancer
No grade 2 or greater peripheral neuropathy due to other medical conditions
No active infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 1 highly effective method and 1 additional method of contraception for 1 month before, during, and for 4 weeks after study for women and effective barrier contraception for men during and for 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No prior biologic therapy for multiple myeloma
No other concurrent biologic therapy for multiple myeloma

Chemotherapy:

No prior chemotherapy for multiple myeloma
No other concurrent chemotherapy for multiple myeloma

Endocrine therapy:

More than 6 months since prior systemic dexamethasone or glucocorticoids
No concurrent corticosteroids

Radiotherapy:

At least 4 weeks since prior palliative, localized radiotherapy
Concurrent palliative, localized radiotherapy allowed at the physician's discretion

Surgery:

Not specified

Other:

No prior systemic therapy for multiple myeloma, except bisphosphonates
No concurrent anticoagulant therapy for deep vein thrombosis
No concurrent barbiturates or alcohol (thalidomide arm)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
2	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010-3000
3	Veterans Affairs Medical Center - Palo Alto	Palo Alto	California	United States	94304-1290
4	Stanford University Medical Center	Stanford	California	United States	94305-5408
5	CCOP - Colorado Cancer Research Program, Inc.	Denver	Colorado	United States	80224
6	CCOP - Christiana Care Health Services	Wilmington	Delaware	United States	19899
7	MBCCOP - Howard University Cancer Center	Washington	District of Columbia	United States	20060
8	Veterans Affairs Medical Center - Gainesville	Gainesville	Florida	United States	32608-1197
9	UF Shands Cancer Center	Gainesville	Florida	United States	32610-0277
10	Veterans Affairs Medical Center - Miami	Miami	Florida	United States	33125
11	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
12	Veterans Affairs Medical Center - Tampa (Haley)	Tampa	Florida	United States	33612
13	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
14	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia	United States	30033
15	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois	United States	60611-3013
16	Veterans Affairs Medical Center - Lakeside Chicago	Chicago	Illinois	United States	60611-4494
17	CCOP - Central Illinois	Decatur	Illinois	United States	62526
18	CCOP - Evanston	Evanston	Illinois	United States	60201
19	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61602
20	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
21	Indiana University Cancer Center	Indianapolis	Indiana	United States	46202-5289
22	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana	United States	46202
23	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
24	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa	United States	52722
25	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
26	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1016
27	Holden Comprehensive Cancer Center	Iowa City	Iowa	United States	52242-1009
28	Veterans Affairs Medical Center - Wichita	Wichita	Kansas	United States	67218
29	MBCCOP - LSU Medical Center	New Orleans	Louisiana	United States	70112
30	CCOP - Ochsner	New Orleans	Louisiana	United States	70121
31	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
32	Tuft-New England Medical Center	Boston	Massachusetts	United States	02111
33	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
34	CCOP - Ann Arbor Regional	Ann Arbor	Michigan	United States	48106
35	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
36	CCOP - Duluth	Duluth	Minnesota	United States	55805
37	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417-2399
38	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
39	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
40	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
41	Veterans Affairs Medical Center - Omaha	Omaha	Nebraska	United States	68105
42	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
43	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
44	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey	United States	07019
45	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
46	Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
47	Albert Einstein Clinical Cancer Center	Bronx	New York	United States	10461
48	MBCCOP-Our Lady of Mercy Cancer Center	Bronx	New York	United States	10466
49	Veterans Affairs Medical Center - Brooklyn	Brooklyn	New York	United States	11209
50	Veterans Affairs Medical Center - New York	New York	New York	United States	10010
51	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York	United States	10016
52	James P. Wilmot Cancer Center	Rochester	New York	United States	14642
53	CCOP - Merit Care Hospital	Fargo	North Dakota	United States	58122
54	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
55	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
56	CCOP - Columbus	Columbus	Ohio	United States	43206
57	CCOP - Toledo Community Hospital	Toledo	Ohio	United States	43623-3456
58	CCOP - Oklahoma	Tulsa	Oklahoma	United States	74136
59	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
60	Hahnemann University Hospital	Philadelphia	Pennsylvania	United States	19102-1192
61	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104
62	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
63	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania	United States	15213-3489
64	Veterans Affairs Medical Center - Pittsburgh	Pittsburgh	Pennsylvania	United States	15240-0001
65	CCOP - MainLine Health	Wynnewood	Pennsylvania	United States	19096
66	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57104
67	Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus	Nashville	Tennessee	United States	37212-2637
68	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6307
69	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
70	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin	United States	54301
71	Veterans Affairs Medical Center - Madison	Madison	Wisconsin	United States	53705-2286
72	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-0001
73	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin	United States	54449
74	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226-3596
75	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin	United States	53295
76	MBCCOP - San Juan	San Juan		Puerto Rico	00927-5800
77	Veterans Affairs Medical Center - San Juan	San Juan		Puerto Rico	00927-5800
78	Pretoria Academic Hospitals	Pretoria		South Africa	0001