The purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in treating newly diagnosed patients with multiple myeloma. The number of patients whose multiple myeloma disappears for a period of time (complete Response) will be studied to make the determination of which treatment is more effective.
This is a multi-center, open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance) study to compare the safety and effectiveness of Thalidomide + Dexamethasone versus DOXIL (doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone in patients with newly diagnosed multiple myeloma. Treatments are administered in 28-day cycles. Patients will receive 4 to 12 treatment cycles, depending on the response of their multiple myeloma to the treatment (measured according to the European Group for Blood and Marrow Transplant Response Criteria). Patients will have additional tests that include Multiple Gated Acquisition (MUGA) scans or echocardiograms to assess the patients for potential cardiotoxicity that could be related to treatment with DOXIL (doxorubicin HCl liposome injection). Maximum duration of study participation for each participant will be 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
225
Participants will receive thalidomide orally every night (at bedtime) without food on days 1-28 and dosing will gradually increase during Cycle 1 starting at 50 mg on 1 to 7 days, 100 mg on 8 to 14 days, 150 mg on 15 to 21 days, and 200 mg 22 to 28 days. Thalidomide 200 mg per day will be administered for subsequent cycles. Participants will receive thalidomide for minimum of 4 cycles and a maximum of 12 cycles.
Participants will receive dexamethasone 40 mg orally on Days 1 to 4, 9 to 12 and 17 to 20.
DOXIL 40 mg/m2 will be administered iintravenously (into a vein) on Day 1.
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Greenbrae, California, United States
Unnamed facility
La Verne, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Denver, Colorado, United States
Unnamed facility
Complete Response Rate: Number of Participants Who Achieved a Complete Response
Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.
Time frame: From Cycle 2 until 28 days following completion of treatment
Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)
Overall response to study medication is defined as number of participants who acheived a complete response (CR) or partial response (PR) by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.
Time frame: From Cycle 2 until 28 days following completion of treatment
Time to 1st Response
Time to first response was defined as the interval from date of randomization to date of achieving a partial response (PR) or better according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.
Time frame: From Cycle 2 until 28 days following completion of treatment
Time to Progression
Time to progression is the interval between the date of randomization until disease progression or death due to progression.
Time frame: From randomization until death or as assessed up to 2 years post last participant last treatment visit
Overall Survival: Number of Participants Died Due to Any Cause
Time frame: From randomization until death or as assessed up to 2 years post last participant last treatment visit
Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)
Time frame: From randomization until death or as assessed up to 2 years post last participant last treatment visit
Engraftment: Number of Participants Who Underwent Engraftment
Engraftment is the process of transplanted stem cells reproducing new cells.
Time frame: From randomization until death or as assessed up to 2 years post last participant last treatment visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
New London, Connecticut, United States
Unnamed facility
Boca Raton, Florida, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Orange City, Florida, United States
...and 48 more locations