Multiple Myeloma and Plasma Cell Neoplasm
Conditions
Keywords
refractory multiple myeloma, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Brief summary
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Interleukin-6 may stimulate the white blood cells to kill cancer cells. Giving interferon alfa together with interleukin-6 may kill more cancer cells. PURPOSE: This clinical trial is studying the side effects and how well giving interferon alfa together with interleukin-6 works in treating patients with recurrent multiple myeloma.
Detailed description
OBJECTIVES: * Determine the response rate in patients with recurrent multiple myeloma treated with recombinant interferon alfa and recombinant interleukin-6. * Determine the safety and optimal dose of this regimen in these patients. * Determine the toxicity of this regimen in these patients. * Determine the impact of this regimen on clonogenic growth of myeloma cells in serial in vitro assays. OUTLINE: This is a pilot study. Patients receive recombinant interferon alfa subcutaneously (SC) once daily. Beginning 1 month later, patients also receive recombinant interleukin-6 SC once daily. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Interventions
BIOLOGICALrecombinant interferon-α
BIOLOGICALrecombinant interleukin-6
Sponsors
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of recurrent multiple myeloma * Must have received ≥ 2 prior therapies PATIENT CHARACTERISTICS: * Performance status 0-3 PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria. | Up to 5 months | Number of participants with partial or complete response by Bladé criteria where partial response is defined as a \>= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with \< 5% plasma cells. |
| Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events | Up to 5 months | Number of participants who discontinued the protocol due to adverse events. |
| Optimal Dose of Interleukin-6 | Up to 5 months | Maximum tolerated dose found using a standard 3+3 dose escalation model. |
| Impact of Treatment on Growth of Myeloma Cells | Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study | Percentage change in growth of in vitro myeloma cells from baseline to end of study. |
Countries
United States
Participant flow
Pre-assignment details
One participant was a screen failure.
Participants by arm
| Arm | Count |
|---|---|
| Interleukin-6 and Interferon-α Subjects will be started on recombinant interferon-α at a dose of 3 million units SQ daily, escalating the dose by 1 million units every week as tolerated to a maximum dose of 3 million units/m2/day. Following a minimum of one month of interferon therapy with two weeks on a stable dose, subjects will begin recombinant interleukin-6 therapy at a dose of 2.5 ug/kg/day.
recombinant interferon-α
recombinant interleukin-6 | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
Baseline characteristics
| Characteristic | Interleukin-6 and Interferon-α |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 54.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Impact of Treatment on Growth of Myeloma Cells
Percentage change in growth of in vitro myeloma cells from baseline to end of study.
Time frame: Day 0, Day 14, Months 1, 2, 4, and 6 of combined therapy, and end of study
Population: Zero participants tolerated protocol therapy and the research sample blood draws were therefore not completed as planned. Because of this, the data from this outcome could not be collected.
Primary
Optimal Dose of Interleukin-6
Maximum tolerated dose found using a standard 3+3 dose escalation model.
Time frame: Up to 5 months
Population: This outcome cannot be evaluated as zero participants tolerated the study regimen. All participants were enrolled on the 2.5 mg arm and a maximum tolerated dose was not found.
Primary
Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria.
Number of participants with partial or complete response by Bladé criteria where partial response is defined as a \>= 50% decrease in serum paraprotein or 90% decrease in urinary light chains (for participants without measurable serum paraprotein). Complete response is defined as negative serum and urine immunofixation and a bone marrow aspirate with \< 5% plasma cells.
Time frame: Up to 5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interleukin-6 and Interferon-α | Response Rate as Assessed by Number of Participants With Partial or Complete Response by Bladé Criteria. | 0 Participants |
Primary
Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events
Number of participants who discontinued the protocol due to adverse events.
Time frame: Up to 5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interleukin-6 and Interferon-α | Toxicity as Measured by Number of Participants Who Discontinued Treatment Due to Adverse Events | 2 Participants |