Celgene High Risk Multiple Myeloma (MM) Revlimid Induction and Maintenance Therapy

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of induction therapy with lenalidomide and low dose dexamethasone followed by sequential low dose bortezomib followed by low dose Melphalan and Prednisone, then followed by low dose lenalidomide for multiple cycles in subjects with high risk Multiple Myeloma (MM). The primary objective is to evaluate the efficacy as measured by the progression free survival (PFS) at 2 years of low dose sequential therapy following four cycles of induction therapy with lenalidomide/low-dose dexamethasone in subjects with symptomatic high risk multiple myeloma, who have received no prior treatment. A total of 35 subjects were estimated to be accrued to this Phase II trial over a period of subjects who are still progression-free at 2 years. Two years will be as measured from date of registration to the trial. Progression will include disease progression (DP) as well as death due to any cause. Data will be analyzed and reported by the PI after 1 and 2 years of initiation of the study. All subsequent data collected may be analyzed and reported in a follow-up clinical report. The PI and independent reviewers will meet to review the efficacy and safety data and determine a risk/benefit analysis in this subject population.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cristina Gasparetto
• Collaborator: Celgene Corporation
• Treatments: Aspirin; BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide; Melphalan; Prednisone; Thalidomide

Criteria

Inclusion Criteria:

1. Understand and voluntarily sign an informed consent form.

2. Age 18 years or older at the time of signing the consent.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Multiple myeloma (MM) diagnosed according to the following standard criteria:

• Monoclonal plasma cells in bone marrow ≥10% and/or presence of biopsy-proven plasmacytoma

• Monoclonal protein present in serum and/or urine Myeloma-related organ dysfunction (1 or more) (C) Calcium elevation in blood (serum calcium >10.5 mg/L or ULN) (R) Renal insufficiency (SCr >2 mg/dL) (A) Anemia (hemoglobin <10 g/dL or 2g5. Measurable disease requiring systemic therapy.

6. High risk multiple myeloma defined by the presence of one or more of the following:

• Deletion of chromosome 13 by metaphase analysis (standard cytogenetics)

• deletion of 17p13 (p53) by Fluorescence in situ hybridization (FISH) or metaphase analysis

• t(4;14) by FISH

• t(14;16) by FISH

• t(8;14) by FISH

• t(14;20) by FISH

• hypodiploidy detected by FISH or metaphase analysis

• any complex cytogenetic abnormality detected by metaphase analysis, with the exception of hyperdiploidy

7. No previous treatment with systemic therapy or radiation therapy lasting more than 4 weeks duration.

8. At least 7 days since date of last radiation or systemic treatment for MM.

9. Eastern Cooperative Oncology Group (ECOG) performance status of < or =2 at study entry.(0=Fully active; 1=Restricted but ambulatory; 2=Ambulatory but unable to work)

10. All study participants must be registered into the mandatory RevAssist® program, and willing and able to comply with the requirements.

11. Females of childbearing potential (FCBP) must have negative pregnancy test with a sensitivity of >/=50 milli-International unit (mIU)/mL within 10-14 days prior to and within 24 hours of prescribing lenalidomide and must use 2 acceptable methods of birth control, one highly effective method and one other effective method AT THE SAME TIME, >4 weeks before taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a latex condom even if he has had a successful vasectomy, if partner is FCBP.

12. Disease free of prior malignancies for >5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast

13. Able to take 325 mg aspirin daily as prophylactic anticoagulation for the duration of protocol therapy.

14. Receive concomitant therapy with bisphosphonates if bony lesions are present at time of enrollment.

Exclusion criteria

1. Any serious medical condition, laboratory abnormality, or psychiatric illness to prevent the subject from signing the consent.

2. Pregnant or breast feeding females.

3. Any condition which places the subject at unacceptable risk or confounds the ability to interpret data from the study.

4. Abnormal laboratory test results within these ranges:

• Absolute neutrophil count < 1.0 x 109/L

• Platelet count < 50 x 109/L (Subjects with severe pancytopenia (not meeting the above criteria) due to myeloma involvement of > 70% bone marrow are eligible)

• Serum creatinine > 2.5 mg/dL or ≥ 3.0 mg/dL if due to multiple myeloma.

• Total bilirubin > 2.0 mg/dl

5. History of allergy to any of the study medications, their analogues, or excipients in the various formulations

6. Concurrent use of other anti-cancer agents or treatments.

7. Known HIV positivity

8. Known Active Hepatitis A, B or C

9. Erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drug.