Aplidin - Dexamethasone in Relapsed/Refractory Myeloma - Full Text View

Sponsor:	PharmaMar
Information provided by:	PharmaMar
ClinicalTrials.gov Identifier:	NCT01102426

Purpose

Study of Plitidepsin in combination with dexamethasone versus dexamethasone alone in patients with relapsed/refractory multiple myeloma.

Condition	Intervention	Phase
Relapsed/Refractory Multiple Myeloma	Drug: plitidepsin + dexamethasone Drug: dexamethasone	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Randomized, Multicenter, Open-label, Phase III Study of Plitidepsin in Combination With Dexamethasone vs. Dexamethasone Alone in Patients With Relapsed/Refractory Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by PharmaMar:

Primary Outcome Measures:

Progression Free Survival (PFS) as per intention-to-treat (ITT) [ Time Frame: Estimated average: 5 months. From randomization to the first evidence of progressive disease or death due to any cause ] [ Designated as safety issue: No ]
To compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM).

Secondary Outcome Measures:

Response rate [ Time Frame: Every 4 weeks untill progression ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: Estimated average: 3 months. From the date of first documentation of response to the date of disease progression or death. ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: Estimated average: 9 months. From randomization to the first evidence of progressive disease or death due to any cause ] [ Designated as safety issue: No ]
Overal Survival (OS) is defined as the time from the date of randomization to the date of death or last contact

Estimated Enrollment:	250
Study Start Date:	June 2010
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm A plitidepsin + dexamethasone combination	Drug: plitidepsin + dexamethasone plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion. Other Name: APLIDIN (plitidepsin)
Active Comparator: Arm B dexamethasone single agent	Drug: dexamethasone 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.

Detailed Description:

Phase III Study in Patients with Relapsed/Refractory Multiple Myeloma to compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone measured by progression-free survival (PFS) and to evaluate tumor response, duration of response (DR) and overall survival (OS). The evaluation of efficacy after crossover from dexamethasone alone to plitidepsin and dexamethasone combination, of safety profile on both arms patients and of pharmacokinetics (PK) and pharmacokinetic /pharmacodynamic (PK/PD) relationship will be performed.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥ 18 years.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
Life expectancy ≥ 3 months.
Patients previously diagnosed with multiple myeloma
Patients must have relapsed or relapsed and refractory multiple myeloma (MM) after at least three but not more than six prior therapeutic regimens for MM, including induction therapy and stem cell transplant in candidate patients, which will be considered as only one regimen.
Patients must have received previous bortezomib-containing and lenalidomide-containing regimens (or thalidomide where lenalidomide is not available)
Women must have a negative serum pregnancy test
Voluntarily signed and dated written informed consent

Exclusion Criteria:

Concomitant diseases/conditions
Women who are pregnant or breast feeding.
Concomitant medications that include corticosteroids, chemotherapy, or other therapy that is or may be active against MM
Known hypersensitivity to any involved study drug or any of its formulation components

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102426

Show 33 Study Locations

Sponsors and Collaborators

PharmaMar

Investigators

Principal Investigator:	Óscar F. Ballester, M.D.	Edwards Comprehensive Cancer Center, Marshall University (Huntington)
Principal Investigator:	Rubén Niesvizky, M.D.	NY Presbyterian Hosp. - Cornell University - NY

More Information

No publications provided

Responsible Party:	Gianluca Laus, Pharma Mar USA, Inc.
ClinicalTrials.gov Identifier:	NCT01102426 History of Changes
Other Study ID Numbers:	APL-C-001-09
Study First Received:	March 31, 2010
Last Updated:	May 17, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by PharmaMar:

Multiple Myeloma
Aplidin
plitidepsin
dexamethasone

Additional relevant MeSH terms:

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
Dexamethasone acetate

Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2012