Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Smoldering Multiple Myeloma

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Precancerous Conditions

Hypergammaglobulinemia

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Melphalan

Lenalidomide

Mechlorethamine

Nitrogen Mustard Compounds

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Phenylalanine

Alanine

Beginning between day 100-110, patients receive lenalidomide PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Beginning between day 100-110, patients receive placebo PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Autologous Hematopoietic Stem Cell Transplantation

Laboratory Biomarker Analysis

Peripheral Blood Stem Cell Transplantation

Placebo Administration

Philip L McCarthy

This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.

PRIMARY OBJECTIVE:

I. To determine the efficacy of CC-5013 (lenalidomide) in prolonging time to disease progression in patients with multiple myeloma after autologous stem cell transplant (ASCT).

SECONDARY OBJECTIVES:

I. To determine if CC-5013 will increase the complete response (CR) rate in patients with multiple myeloma following ASCT.

II. To compare the progression-free survival (PFS) and overall survival (OS) in patients with multiple myeloma who have undergone ASCT and who then are randomized to either CC-5013 or placebo.

III. To determine the feasibility of long-term administration of CC-5013 to multiple myeloma patients who have undergone ASCT.

OUTLINE:

PERIPHERAL BLOOD STEM CELL (PBSC) MOBILIZATION: Mobilization of autologous PBSC will be performed according to institutional guidelines.

AUTOLOGOUS PBSC TRANSPLANTATION (PBSCT): Patients receive melphalan intravenously (IV) over 30-60 minutes on day -2 or -1 or over 2 days on days -3 and -2 or -2 and -1. Patients undergo autologous PBSCT on day 0.

Patients are then randomized to 1 of 2 maintenance treatment arms. (Note: As of 12/17/09, no more patients will be randomized between lenalidomide and placebo. Patients who have not been randomized as of 12/17/09 will be assigned to lenalidomide.)

ARM I: Beginning between day 100-110, patients receive lenalidomide orally (PO) once daily.

ARM II: Beginning between day 100-110, patients receive placebo (PO) once daily.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter.

Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 (NSC # 703813) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma

Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.

Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.

Progression was defined per the International Myeloma Working Group definition as one more of the following:

* 25% increase in serum M-component (absolute increase \>= 0.5g/dl)
* 25% increase in urine M-component (absolute increase \>= 200mg/24hour
* 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl)
* 25 % increase in bone marrow plasma cell percentage (absolute increase of \>=10%)
* Definite development of new bone lesion or soft tissue plasmacytomas
* Development of hypercalcemia

Response was defined according to International Myeloma Working Group criteria (2006)

* Complete Response: Complete disappearance of M-protein from serum \& urine on immunofixation, normalization of Free Light Chain (FLC) ratio \& \<5% plasma cells in bone marrow (BM)
* Partial Response: \>= 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
* Marginal Response: 25-49% reduction in serum M-component \& urine M-component by 50-89% which still exceeds 200mg/24hour
* Progressive Disease: Defined in primary outcome measure
* Stable Disease: Not meeting any of the criteria above

National Cancer Institute (NCI)

Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

Lenalidomide Maintenance

Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

(closed as of 12/17/09)

Placebo Maintenance

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

> 2.5 mg/liter

<= 2.5 mg/liter

Missing data

Beta 2 microglobulin at registration

Prior use of thalidomide during induction

Prior use of lenalidomide during induction therapy

Philip McCarthy, MD

Time to Progression

Complete response

Partial response

Marginal response

Stable disease

Progressive disease

Unknown

Beginning between day 100-110, patients receive oral lenalidomide once daily.

Beginning between day 100-110, patients receive oral placebo once daily.

(closed as of 12/17/09)

Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100

Overall Survival

Patients who develop progression (defined in primary outcome measure), died or develop a new primary malignancy (cancer) will summarized in this outcome.

Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy

Overall Study

Anti-Infective Agents

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Antipyretics

Antirheumatic Agents

Fibrinolytic Agents

Analgesics

Platelet Aggregation Inhibitors

Dermatologic Agents

Thalidomide

Dexamethasone

Aspirin

Dexamethasone acetate

BB 1101

Ichthammol

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Patients receive lenalidomide PO QD on days 1-21 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.

Patients receive lenalidomide and acetylsalicylic acid as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

Patients with no response after treatment on Arm I: Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20

Patients with no response after treatment on Arm II: Patients receive thalidomide as in arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

S. V Rajkumar

This randomized phase III trial studies lenalidomide and low-dose dexamethasone to see how well it works compared to lenalidomide and standard-dose dexamethasone, given with or without thalidomide, in treating patients with multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide and thalidomide may also stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as 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, thalidomide, and dexamethasone together may kill more cancer cells.

PRIMARY OBJECTIVE:

I. To evaluate the response rate and toxicity of lenalidomide (CC-5013) plus dexamethasone (standard dose) versus CC-5013 plus low dose dexamethasone in patients with newly diagnosed myeloma at any time in the first 4 cycles of treatment and to determine if CC-5013 plus low dose dexamethasone will have similar response rate with lower toxicity (First Phase).

SECONDARY OBJECTIVES:

I. To evaluate the response rate of thalidomide plus dexamethasone (Thal/Dex) in patients with newly diagnosed myeloma who do not achieve a complete or partial response at any time in the first 4 cycles with the CC-5013 and dexamethasone combination in either of the two arms (First Phase).

II. To study the effect of CC-5013 on bone marrow microvessel density and angiogenesis grade, on plasma cell labeling index (PCLI), and on the expression of vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in the marrow (First Phase).

III. To study the effect of CC-5013 and dexamethasone on bone marrow mesenchymal progenitor cells (MPCs) (First Phase).

IV. To evaluate in a separate expansion phase the efficacy of aspirin (325 mg/day) versus Coumadin (dose adjusted to maintain a target international normalized ratio \[INR\] of 2-3) in preventing deep vein thrombosis (DVT) in patients with newly diagnosed myeloma receiving CC-5013 plus standard dose dexamethasone.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21, and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.

Arm II: Patients receive lenalidomide as in Arm I and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

In both arms, cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients not responding at any point during the first 4 cycles of lenalidomide and dexamethasone are assigned to 1 of 2 salvage therapy arms. Patients who progress during treatment on Arms I or II have the option to register on salvage therapy Arms III or IV respectively.

Arm III (patients with no response after treatment on Arm I): Patients receive thalidomide PO QD on days 1-28 and standard-dose dexamethasone PO QD on days 1-4, 9-12, and 17-20.

Arm IV (patients with no response after treatment on Arm II): Patients receive thalidomide as in Arm III and low-dose dexamethasone PO QD on days 1, 8, 15, and 22.

In both salvage therapy arms, cycles repeat every 28 days in the absence of unacceptable toxicity or disease progression. After completion of 4 cycles of therapy, patients may undergo stem cell harvest (using growth factors only) for cryopreservation.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years.

Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma

A Randomized Phase III Study of CC-5013 Plus Dexamethasone Versus CC-5013 Plus Low Dose Dexamethasone in Multiple Myeloma With Thalidomide Plus Dexamethasone Salvage Therapy for Non-Responders

Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to \<200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).

As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only.

Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.

Arm I (Lenalidomide, Dexamethasone) Step 1

Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.

Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1

Arm I patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.

Arm I (Lenalidomide, Dexamethasone) Step 2

Arm II patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.

Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2

Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.

Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)

Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.

Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)

Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.

As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.

Arm I (Lenalidomide, Dexamethasone)

Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.

As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase.

Arm II (Lenalidomide, Low-dose Dexamethasone)

Study Statistician

The study was designed to determine if a reduced dose of dexamethasone in combination with CC-5013 reduced toxicity rate without reducing response rate. The standard-dose response was expected to be 70%. The low dose would be deemed unacceptable if the difference in response rate between arms was \>=15%. The null hypothesis was that response rates were equal and the alternative was that the low-dose response was no worse than 55%. The design had a 1-sided 0.10 type I error rate and 95% power.

Only eligible patients were included in this analysis.

Proportion of Patients With Objective Response (First Phase, Step 1)

Proportion of Patients With Objective Response (First Phase, Step 2)

Step 1

Step 2

Bortezomib

Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Brian M Durie

This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.

PRIMARY OBJECTIVES:

I. To compare progression-free survival (PFS) in patients with newly diagnosed myeloma treated with lenalidomide plus low dose dexamethasone versus bortezomib plus lenalidomide and low dose dexamethasone.

SECONDARY OBJECTIVES:

I. Assess response using the new international response criteria. II. To bank specimens for future translational medicine research. III. Follow patients to assess overall survival and other long-term outcomes stratified by intent to transplant at progression.

TERTIARY OBJECTIVES:

I. To evaluate custom and genome-wide single nucleotide polymorphisms in correlation with biology, prognosis and outcome for both treatment regimens combined; to verify the findings recently obtained with the custom Bank on a Cure program (BOAC) single nucleotide polymorphism (SNP) chip on Total Therapy 2 (TT2) data with respect to bone disease in the cooperative group setting.

II. To use baseline gene expression profiling as a tool to evaluate the biology, prognostic and risk factors, and response to therapy for both treatment regimens combined. To validate John Shaughnessy's 70 gene risk model developed for Total Therapy 2 (TT2) in the cooperative group setting.

OUTLINE:

INDUCTION THERAPY: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive dexamethasone orally (PO) once daily (QD) on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

In both arms, patients who intend to undergo transplantation at relapse undergo peripheral blood stem cell collection, preferably after course 2.

MAINTENANCE THERAPY: After the completion of at least 4 courses (Arm I) or at least 6 courses (Arm II) of induction therapy, patients receive maintenance therapy comprising dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically for up to 6 years.

Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma

A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant

Unstratified median progression-free survival in months.

Unstratified median overall survival in months.

The response rate was calculated as the number of patients with documented confirmed partial response (PR) or better, which includes confirmed/unconfirmed stringent complete response (sCR), confirmed/unconfirmed complete response (CR), confirmed/unconfirmed very good partial response (VGPR), or confirmed partial response (PR), as best response divided by the total number of evaluable patients, in each arm. Patients with measurable disease, as defined in the protocol, are evaluable. Response rates were compared between the two treatment arms using a stratified Cochran-Mantel-Haenszel test. Response designations were based on the International Uniform Response Criteria for Multiple Myeloma. Due to the complexity of these criteria, the details of these criteria have been omitted.

The number at risk excludes patients who went off study prior to starting treatment and were thus not evaluated for toxicity. The adverse events reported here are current up through the time of upload of these data.

Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Dexamethasone: Given PO

Laboratory Biomarker Analysis: Optional correlative studies

Lenalidomide: Given PO

Arm I (Dexamethasone and Lenalidomide)

Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.

Bortezomib: Given IV

Dexamethasone: Given PO

Laboratory Biomarker Analysis: Optional correlative studies

Lenalidomide: Given PO

Arm II (Dexamethasone, Lenalidomide, Bortezomib)

Age, Categorical

International Staging System (ISS) Criteria:

Stage I: Serum β2-microglobulin \< 3.5mg/L and Serum Albumin ≥ 3.5 g/dL; expected median survival is 62 months. Stage II\*: Not Stage I or III; expected median survival is 44 months. Stage III: Serum β2-microglobulin \> 5.5 mg/L; expected median survival is 29 months.

\*There are two categories for stage II: serum β2-microglobulin \< 3.5 mg/L but serum albumin \< 3.5 g/dL; or serum β2-microglobulin 3.5 to \< 5.5 mg/L irrespective of the serum albumin level.

ISS Stage

Includes all eligible and analyzable patients.

With four years of patient accrual and two and a half years of follow-up, 220 patients per arm yields 87% power to detect an increase of PFS of 50%, from a median of 3 years to 4.5 years, which corresponds to a hazard ratio of 1.5. These calculations are based on a one-sided stratified log-rank test at level 0.025 with two interim analyses. The final analysis will be carried out at the 0.02 significance level to allow for two interim analyses at the 0.0025 significance level.

All eligible and analyzable patients are included. An analyzable patient is one who provided valid consent and who did not withdraw consent prior to initiating treatment.

Progression-free Survival

Overall survival will be compared between the two treatment arms using a stratified log-rank test.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant	NCT00114101	DS Stage I Mult... DS Stage II Mul... DS Stage III Mu... Refractory Mult... Smoldering Mult...	Autologous Hema... Laboratory Biom... Lenalidomide Melphalan Peripheral Bloo... Placebo Adminis...	18 Years - 70 Years	National Cancer Institute (NCI)
Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant	NCT00114101	DS Stage I Mult... DS Stage II Mul... DS Stage III Mu... Refractory Mult... Smoldering Mult...	Autologous Hema... Laboratory Biom... Lenalidomide Melphalan Peripheral Bloo... Placebo Adminis...	18 Years - 70 Years	National Cancer Institute (NCI)
Lenalidomide and Dexamethasone With or Without Thalidomide in Treating Patients With Multiple Myeloma	NCT00098475	DS Stage I Mult... DS Stage II Mul... DS Stage III Mu...	Dexamethasone Laboratory Biom... Lenalidomide Thalidomide	18 Years -	National Cancer Institute (NCI)
Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant	NCT00114101	DS Stage I Mult... DS Stage II Mul... DS Stage III Mu... Refractory Mult... Smoldering Mult...	Autologous Hema... Laboratory Biom... Lenalidomide Melphalan Peripheral Bloo... Placebo Adminis...	18 Years - 70 Years	National Cancer Institute (NCI)
Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma	NCT00644228	DS Stage I Mult... DS Stage II Mul... DS Stage III Mu...	Bortezomib Dexamethasone Laboratory Biom... Lenalidomide	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for ds stage i multiple myeloma