Multiple Myeloma
Conditions
Keywords
Myeloma, Thalidomide, Pamidronate, Aredia, Bisphosphonate, Anti-Angiogenesis, Smoldering/Indolent Myeloma, Zometa
Brief summary
The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any side effects.
Detailed description
Recently laboratory research found that thalidomide can inhibit the formation of new blood vessels that are necessary for the growth and spread of cancer. In order to grow and increase in size tumors require new blood vessels to supply them with the necessary blood to grow. If we can prevent these new blood vessels feeding the tumor from being formed by using thalidomide we might slow or stop the growth of the tumor. This concept is called anti-angiogenesis It is hoped that thalidomide will slow or stop the growth myeloma. However, it cannot be guaranteed that you will benefit if you take part in this study. The treatment you receive may even be harmful.
Interventions
DRUGPamidronate
Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.
DRUGThalidomide
All Patients will receive thalidomide 200 mg as an oral, once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met. Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose)
DRUGZometa
Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 4 mg every 4 weeks as maintenance therapy.
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have a diagnosis of Smoldering or Indolent myeloma * All patients must be informed of the investigational nature of this study and must sign a written informed consent in accordance with UAMS Human Research Advisory Committee and federal guidelines.
Exclusion criteria
* Prior bisphosphonate therapy within 30 days prior to study entry. * Serum creatinine \> 5 mg/dl, ascites, or serum direct bilirubin \> 2.5 mg/dl. * Prior plicamycin or calcitonin within 2 weeks of study entry. * Severe cardiac disease, unstable thyroid disease, or epilepsy. * Prior radiation therapy to \> 20% of the skeleton.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best Response | 2 years | Best response to study treatment as defined by protocol-specific response criteria: Complete Response (CR) = absence of urine and serum M-components by immunofixation; bone marrow should be adequately cellular (\>20%) with \<1% monoclonal plasma cells by DNA-clg flow cytometry; serum calcium level must be normal; no new bone lesions nor enlargement of existing lesions; Normalization of serum concentrations of normal immunoglobulins is not required for CR. Partial Response (PR) = Reduction by \> 75% in serum myeloma protein production; Decrease in monoclonal marrow plasmacytosis to \<5%; Decrease in Bence-Jones proteinuria by \>90%; No new lytic bone lesions or soft tissue plasmacytoma. Treatment Failures/Progressive Disease (PD) = Such patients do not fulfill the above criteria and/or have new lytic lesions (but not compression fractures), hypercalcemia, or other new manifestations of disease. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Thalidomide + Bisphosphonate 200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy | 83 |
| Total | 83 |
Baseline characteristics
| Characteristic | Thalidomide + Bisphosphonate |
|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 83 / 83 |
| serious Total, serious adverse events | 16 / 83 |
Outcome results
Primary
Best Response
Best response to study treatment as defined by protocol-specific response criteria: Complete Response (CR) = absence of urine and serum M-components by immunofixation; bone marrow should be adequately cellular (\>20%) with \<1% monoclonal plasma cells by DNA-clg flow cytometry; serum calcium level must be normal; no new bone lesions nor enlargement of existing lesions; Normalization of serum concentrations of normal immunoglobulins is not required for CR. Partial Response (PR) = Reduction by \> 75% in serum myeloma protein production; Decrease in monoclonal marrow plasmacytosis to \<5%; Decrease in Bence-Jones proteinuria by \>90%; No new lytic bone lesions or soft tissue plasmacytoma. Treatment Failures/Progressive Disease (PD) = Such patients do not fulfill the above criteria and/or have new lytic lesions (but not compression fractures), hypercalcemia, or other new manifestations of disease.
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Thalidomide + Bisphosphonate | Best Response | Partial Response | 17 participants |
| Thalidomide + Bisphosphonate | Best Response | Complete Response | 10 participants |
| Thalidomide + Bisphosphonate | Best Response | Treatment Failure/Progressive Disease | 56 participants |