Evaluation of Lenalidomide, Doxorubicin and Dexamethasone (RAD) in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, open label, uncontrolled, non-comparative phase I/II study in patients with refractory or relapsed multiple myeloma who are eligible for second, third, or fourth line therapy. Patients will be enrolled sequentially into four dose cohorts. The feasibility of administrating Revlimid (R) in combination with Doxorubicin and Dexamethasone (AD) and the MTD of the combination will be determined in the phase I part of the study (Part A). When the MTD has been established, the efficacy of the combination will be further evaluated in the phase II part of the study Part B)

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wuerzburg
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Lenalidomide

Criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study

1. Understand and voluntarily sign an informed consent form.

2. Age > 18 years at the time of signing the informed consent form.

3. Multiple myeloma with Durie-Salmon stage II or III and considered to have disease progression after at least 1 previous anti-myeloma regimen (examples: induction chemotherapy followed by stem cell collection and high dose chemotherapy and autologous PBSCT; MP; anthracycline-containing regimen > 3 months ago, any other conventional regimen including thalidomide- or bortezomib containing regimens.

4. Subjects must have not have recieved more than 3 previous anti-myeloma regimens and must be relapsed or refractory following at least one regimen of anti-myeloma therapy.

5. No anthracycline-containing regimen (e.g. VAD) within the last 3 months of study.

6. Subjects may have been previously treated with thalidomide or bortezomib.

7. Radiation therapy after start of the protocol will be considered as treatment failure except when given to treat pathological fractures or preexisting osteolytic lesions.

8. Patients must have measurable levels of myeloma paraprotein in serum (>0.5 g/dl) or urine (>0.2 g excreted in a 24-hour collection sample).

9. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

10. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting each cycle. Men and WCBP must agree to use adequate contraceptive methods.

11. Must have a 2-d echocardiogram indicating LVEF ≥ 55% within 42 days prior to first dose of study drug.

12. Life extpectancy > 3 months.

Exclusion criteria:

The presence or any of the following will exclude a subject from study enrollment.

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that makes the patient ineligeble for the study. Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma.

2. Pregnant or lactating females.

3. Heart failure (EF < 55%).

4. Any of the following laboratory abnormalities Absolute neutrophil count (ANC) <1500/mm3 (1x109/L) Platelet count (PLT) <100000/mm3 Serum creatinine> 2.5 mg/dL SGOT and SGPT > 3 x upper limit of normal (ULN) Serum total bilirubin >1.2 mg/dL

5. Prior history of any other malignancies except for adequately treated basal cell, insitu cervical or breast cancer or other for which the patient has been disease free for 5 years.

6. Known hypersensitivity to thalidomide, dexamethasone and/or anthracyline.

7. Prior use of Revlimid.

8. Anthracycline-containing regimen (e.g. VAD) within the last 3 months of study.

9. Any history of thrombembolic events

10. Use of any standard or experimental anti-myeloma drug therapy within 28 days of study enrolment.

11. Major surgery or radiotherapy within 4 weeks of study enrolment.

12. Active infection requiring antibiotic therapy.

13. Subjects who have received > 300 mg/m2 lifetime cumulative dose of doxorubicin alone, or Doxil® alone, or doxorubicin plus Doxil®.

14. History of cardiac disease, with New York Heart Association Class II or greater (See Appendix VII).

15. Known HIV or hepatitis B or C positive.

16. No more than 3 prior anti-myeloma regimens.