Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma
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ClinicalTrials.gov Identifier: NCT00086216 |
Recruitment Status :
Completed
First Posted : June 30, 2004
Last Update Posted : December 21, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Myeloma | Drug: Atiprimod | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Study of the Safety and Efficacy of Atiprimod Treatment for Patients With Refractory or Relapsed Multiple Myeloma |
Study Start Date : | May 2004 |
Actual Study Completion Date : | November 2007 |

- Drug: Atiprimod
Oral, once a day, 14 days on 14 days off
- The primary objective of this study is to identify the maximum tolerated dose [ Time Frame: 1 year ]
- The secondary objective of this study is to measure the pharmacokinetics of [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- documented history of multiple myeloma,
- failed at least two prior regimens for multiple myeloma,
- 18 years of age or older,
- ECOG(Zubrod)PS of 0 to 2,
- screening evaluation for determining eligibility prior to enrollment,
- signed informed consent form,
Exclusion Criteria:
- concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,
- renal insufficiency (serum creatinine levels of > 2mg/dL),
- mucosal bleeding,
- any condition which in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study.
- clinically relevant active infection or co-morbid medical conditions.
- prior malignancy(within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient is has been disease-free for at least 3 years.
- patients with non-secretory myeloma.
- as atiprimod is a potent inhibitor or CYP2D6, patients taking drugs that are substrates of CYP2D6(e.g. beta blockers, antidepressants and antipsychotics) will be excluded.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00086216
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Director: | Gary Jacob, PhD | Callisto Pharmaceuticals |
Responsible Party: | Gary Jacob, Callisto Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00086216 |
Obsolete Identifiers: | NCT00301977, NCT00491972 |
Other Study ID Numbers: |
CP-101 efficacy pharmacokinetics research markers |
First Posted: | June 30, 2004 Key Record Dates |
Last Update Posted: | December 21, 2007 |
Last Verified: | December 2007 |
Multiple myeloma |
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |