Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Dexamethasone

Cyclophosphamide

Melphalan

Plerixafor

Lenograstim

Lenalidomide

Dexamethasone acetate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :

* stem cell transplant right after collection
* continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.

All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :

stem cell transplant right after collection

* continue lenalidomide and dexamethasone
* saving stem cell transplant for a later time.

After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.

On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.

Stem cell transplant x 1 or x 2

Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.

lenalidomide and dexamethasone

Hani Hassoun, MD

The purpose of this study is to compare the effects, good and bad, of two ways to treat patients with standard-risk symptomatic multiple myeloma. Patients with standard-risk myeloma have myeloma with specific features: levels of 2 blood tests have to be in a specific range and there can be no myeloma tumors found outside of the bones or bone marrow, the areas where myeloma is usually discovered. In past clinical studies, patients with standard-risk myeloma have done well with intensive therapy in the form of stem cell transplant. But multiple myeloma is not curable and, although it may respond to standard treatments including stem cell transplant, myeloma always recurs.

Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L

A Phase II Clinical Trial for Untreated Patients With Multiple Myeloma Eligible for Stem Cell Transplant: Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L

VGPR/Very Good Partial Response + CR/Complete Response (\>/= VGPR) for each study arm

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Tufts Medical Center

Lahey Clinic

Memorial Sloan Kettering Cancer Center

All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :

stem cell transplant right after collection

* continue lenalidomide and dexamethasone
* saving stem cell transplant for a later time.

lenalidomide and dexamethasone: Patients will then be randomized to continued Ld or high-dose melphalan with SCT. On the SCT arm patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients after one or two SCT, will receive maintenance L.

Continue Lenalidomide and Dexamethasone

All patients on this study start with the same treatment, lenalidomide and dexamethasone by mouth. After patients have received 4 cycles of lenalidomide and dexamethasone and are within 2 weeks of completing stem cell collection, they are randomized (like the toss of a coin) to either :

* stem cell transplant right after collection
* continue lenalidomide and dexamethasone, saving stem cell transplant for a later time.

Stem cell transplant x 1 or x 2: After 4 cycles of Ld, eligible patients will undergo stem cell mobilization and collection with standard-of-care cyclophosphamide and Neupogen (G-CSF) or with plerixafor G-CSF. Mobilization with cyclophosphamide is preferred, but plerixafor is also allowed. Ld will be held for at least 2 weeks prior to stem cell mobilization.

On the SCT arm, patients not achieving VGPR by 3 months after the 1st SCT will undergo a 2nd SCT. All patients, after one or two SCT, will receive maintenance L.

Stem Cell Transplant x 1 or x 2

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Hani Hassoun, MD

Progression Free Survival (PFS) Rate at 2 Years After Enrollment in Untreated Patients With Multiple Myeloma.

Number of Participants With VGPR + CR Rate

Overall Response Rates

Overall Survival

Participants were not randomized and are not evaluable

Not Evaluable

Overall Study

One dose of TJ202 will be given on Day 1 and Day 4 of Week 1, respectively, every week from Week 2 to Week 12, every 2 weeks from Week 13 to Week 24 and then every 4 weeks thereafter.Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg will be administered on Day 1 and Day 4 of Week 1, respectively and then 40mg weekly thereafter.

TJ202, Lenalidomide and Dexamethasone

Lenalidomide 25mg will be administered orally on Days 1 through 21 of each 28-days cycle.Dexamethasone 40 mg weekly will be administered.

Lenalidomide and Dexamethasone

A phase 3, randomized, open-label, parallel-controlled, multi-center study comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in subjects with relapsed or refractory multiple myeloma who received at least 1 prior line of treatment

TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

A Phase 3, Randomized, Open-label, Parallel-controlled, Multi-center Study Comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Who Received at Least 1 Prior Line of Treatment

defined as the duration from the date of randomization to either PD, according to the IMWG criteria, or death, whichever occurs first

TJ Biopharma Co., Ltd.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Renal Insufficiency

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Lenalidomide:Daily for 21 days of a 28 day cycle

Dexamethasone:Days 1-4, 9-12, 17-20 for the first cycle and then weekly dexamethasone from cycles 2-4.

Lenalidomide:Daily for 21 days of a 28 day cycle Dexamethasone:Days 1-4, 9-12, 17-20 for the first cycle and then weekly dexamethasone from cycles 2-4.

Primary:

• To validate the initial dosing recommendations for newly diagnosed MM (Mutiple Myeloma) patients with various degrees of renal failure using pharmacokinetic studies

Secondary:

* To evaluate the safety of lenalidomide and dexamethasone as induction therapy in newly-diagnosed MM (Multiple Myeloma) patients with renal dysfunction using modified dosing guidelines
* To evaluate clinical response of lenalidomide and dexamethasone after 4 cycles using the modified dosing guidelines
* To evaluate the ability to collect stem cells after 4 cycles of lenalidomide and dexamethasone induction therapy in MM (Multiple Myeloma) patients with renal failure

STUDY DESIGN:

This is a single institution open label, pharmacokinetic validation study of the combination of lenalidomide with dexamethasone for firstline induction therapy in transplant-eligible MM ( Multiple Myeloma ) patients with various degrees of renal failure. There will be 4 patient groups with various degrees of renal function (based on creatinine clearance calculated from a 24 hour urine collection and requirement for dialysis). Each group will receive lenalidomide dosing as per official recommended guidelines:

Group 1 Normal {CrCl(creatinine clearance)\>60 mL/min}25 mg (full-dose)-Daily for 21 days of a 28 Day cycle1 Group 2 Moderate renal impairment {30 ≤ CrCl (creatinine clearance) \<60 mL/min}10 mg Daily for 21 days of a 28 day cycle Group 3 Severe renal impairment {CrCl (creatinine clearance)\<30 mL/min, not requiring dialysis}15 mg Every 48 hours for 21 days of a 28 day cycle (11 PLANNED DOSES EACH 28 DAY CYCLE) Group 4 End-stage renal failure {CrCl (creatinine clearance)\<30 mL/min, requiring dialysis}5 mg Once daily for 21 days of a 28 day cycle On dialysis days the dose should be administered following dialysis.

Pharmacokinetic (PK) studies: We will be evaluating PK studies following single and multiple doses of lenalidomide during Cycle 1.Patients will receive their first dose of lenalidomide (Cycle 1, day 1) as per the above designated patient group. PK (pharmacokinetic)sampling for 1st dose only will be drawn at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours post-dose for group 1 and at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48, 72 hours for all other groups. The 2nd dose of lenalidomide will be administered on Day 4 for all patients (i.e. no doses on Days 2 and 3). On Day 17 (after 14 doses of lenalidomide administered), repeat PK sampling will be performed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24 hours for groups 1, 2 and 4 (before next hemodialysis for those in group 4). Repeat PK sampling for group 3 will be performed at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 48 hours.

Lenalidomide & High Dose Dexamethasone for Untreated Multiple Myeloma Renal Failure Patients

An Open-label, Pharmacokinetic Study of Lenalidomide (Revlimid) and High-dose Dexamethasone Induction Therapy in Previously Untreated Multiple Myeloma Patients With Various Degrees of Renal Dysfunction - Validation of Official Dosing Guidelines for Renal Failure

PK data will be analyzed and reported after completion of PK studies in all patients

All patients will be evaluable for toxicity from the time of their first treatment with Lenalidomide and dexamethasone.

All patients who have received at least 1 cycle of therapy and have their disease re-evaluated will be considered evaluable for response.

University Health Network, Toronto

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L	NCT00807599	Multiple Myelom...	Stem cell trans... lenalidomide an...	18 Years - 75 Years	Memorial Sloan Kettering Cancer Center
Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell Transplantation (SCT) Plus Maintenance L	NCT00807599	Multiple Myelom...	Stem cell trans... lenalidomide an...	18 Years - 75 Years	Memorial Sloan Kettering Cancer Center
TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma	NCT03952091	Multiple Myelom... Refractory Mult...	TJ202, Lenalido... Lenalidomide an...	18 Years -	TJ Biopharma Co., Ltd.
Lenalidomide & High Dose Dexamethasone for Untreated Multiple Myeloma Renal Failure Patients	NCT01270932	Renal Failure Multiple Myelom...	Lenalidomide an...	18 Years -	University Health Network, Toronto

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