Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01849783
• Date of registration: 06/05/2013
• Prospective Registration: No
• Primary sponsor: Yogesh Jethava
• Public title: Autologous Stem Cell Transplant Followed By Maintenance Therapy in Treating Elderly Patients With Multiple Myeloma
• Scientific title: Single Autologous Transplant Followed by Consolidation and Maintenance for Participants = 65 Years of Age Diagnosed With Multiple Myeloma or a Related Plasma Cell Malignancy
• Date of first enrolment: April 4, 2013
• Target sample size: 41
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01849783
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Yogesh Jethava
• Affiliation: University of Iowa

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants must have had a diagnosis of symptomatic multiple myeloma (MM), MM +
amyloidosis, or POEMS (osteosclerotic myeloma: polyneuropathy, organomegaly,
endocrinopathy, monoclonal protein, skin changes) requiring treatment; participants
with a previous history of smoldering myeloma will be eligible if there is evidence of
progressive disease requiring chemotherapy; Note that study participants do not need
to have active disease at the time of study entry, as participants may have received
up to 12 months of prior chemotherapy, which might have induced a response

- Protein criteria must be present at diagnosis (quantifiable M-component of IgG, IgA,
IgD, or IgE and/or urinary kappa or lambda light chain, Bence-Jones protein, or Free
Kappa Light Chain or Free Lambda Light Chain) in order to evaluate response.
Non-secretory participants are eligible provided the participant has > 20%
plasmacytosis OR multiple (=3) plasmacytomas or lesions on MRI at the time of
diagnosis or study enrollment , OR the presence of lesions on PET/CT scan or skeletal
survey at diagnosis or study enrollment.

- Participants must have received =12 months of prior chemotherapy for this disease
without evidence of progressive disease with treatment. Participants may have received
prior radiotherapy provided approval has been obtained from the PI. Participants with
a history of radiation who have a platelet count <150,000 due to radiation (disease,
chemo, and other factors have been ruled out) will be excluded from this study.

- Participants must not have had a prior transplant

- Participants must be 65-85 years of age at the time of study entry.

- Ejection fraction by echocardiogram (ECHO) or multigated acquisition scan (MUGA) of >=
40% performed

- Participants must have adequate pulmonary function studies (PFTs), >= 50% of predicted
on mechanical aspects (forced expiratory volume in 1 second [FEV^1}, forced vital
capacity [FVC]) and diffusion capacity (diffusion capacity of the lung for carbon
monoxide [DLCO]) >= 50% of predicted (adjusted for hemoglobin); if the participant is
unable to complete pulmonary function tests (PFTs) due to disease-related pain or
other circumstances that make it difficult to reliably perform PFTs, documentation of
pulmonary function adequate for transplant will occur via a CT scan without evidence
of major pulmonary disease, and arterial blood gas results

- Participants must have a creatinine < 3 mg/dl and a GFR >30mL/min/1.73m2

- Participants must have a performance status of 0-2 based on Eastern Cooperative
Oncology Group (ECOG) criteria; participants with a poor performance status (3-4)
based solely on bone pain will be eligible, provided there is documentation to verify
this

- Participants must sign the most current institutional review board (IRB)-approved
study (informed consent form) ICF

Exclusion Criteria:

- Prior autologous or allogeneic transplant

- Progressive disease on prior treatment

- Platelet count < 30 x 10^9/L, unless myeloma-related; if MM-related (hypercellular
marrow biopsy of > 80% and packed with at least 80% plasma cells) the enrolling
investigator must document this

- > Grade 3 neuropathy

- Known hypersensitivity to bortezomib, boron, or mannitol

- Uncontrolled diabetes on appropriate therapy

- Recent (=< 6 months) myocardial infarction, unstable angina, difficult to control
congestive heart failure, uncontrolled hypertension on appropriate therapy, or
difficult-to-control cardiac arrhythmias

- Participants must not have a creatinine >3 mg/dl or a GFR <30mL/min/1.73m2.

- Participants must not have a concurrent malignancy unless it can be adequately treated
by non-chemotherapeutic intervention; participants may have a history of prior
malignancy, provided that he/she has not had any chemotherapy within 365 days of study
entry AND that life expectancy exceeds 5 years at the time of study entry

- Participants must not have life-threatening co-morbidities



Age minimum: 65 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Light Chain Deposition Disease

Stage II Multiple Myeloma

Isolated Plasmacytoma of Bone

Primary Systemic Amyloidosis

Stage III Multiple Myeloma

Stage I Multiple Myeloma

Extramedullary Plasmacytoma

Intervention(s)

Drug: thalidomide

Drug: doxorubicin

Drug: cisplatin

Drug: bortezomib

Drug: cyclophosphamide

Drug: melphalan

Procedure: autologous stem cell transplant

Drug: etoposide

Drug: dexamethasone

Primary Outcome(s)

Examine treatment related severe complications and toxicities [Time Frame: From the start of DPACE for all participants who have had at least one day of protocol treatment, assessed up to 4 years]

Evaluate the Progression Free Survival (PFS) [Time Frame: From the start of DPACE for all participants who have had at least one day of protocol treatment, assessed up to 4 years]

Secondary Outcome(s)

Assess Quality-Of-Life indicators post-transplant [Time Frame: Once per year, for 3 years, post-transplant]

Secondary ID(s)

NCI-2013-00883

P30CA086862

10120146

201208775

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)