Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-12-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Pamidronate

Intervention Type DRUG

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.

Thalidomide

Intervention Type DRUG

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)

Zometa

Intervention Type DRUG

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.

Interventions

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Pamidronate

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.

Intervention Type DRUG

Thalidomide

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)

Intervention Type DRUG

Zometa

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No